510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD August 2023
DEVICE: Maxiocel Chitosan Wound Dressing
Advamedica Inc. 510(k) NO: K212766(Traditional)
ATTN: Leo Mavely PHONE NO : 1 973 7187575
Harvard Square, 1 Mifflin Place, SSE DECISION MADE: 24-AUG-23
Cambridge MA 02138 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Accu-Chek Guide Solo diabetes manager blood glucose monitoring system
Roche Diabetes Care GmbH 510(k) NO: K213131(Traditional)
ATTN: Wolfgang Handel PHONE NO : 49 621 7598331
Sandhofer Strasse 116 SE DECISION MADE: 10-AUG-23
Mannheim DE 68305 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Accu-Chek Solo micropump system with interoperable technology
Roche Diabetes Care GmbH 510(k) NO: K213134(Traditional)
ATTN: Wolfgang Handel PHONE NO : 49 621 7598331
Sandhofer Strasse 116 SE DECISION MADE: 10-AUG-23
Mannheim DE 68305 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MedicloseTM System
Health Value Creation BV, trading 510(k) NO: K213271(Traditional)
ATTN: Kim Sondeijker PHONE NO : 31 43 3882948
Oxfordlaan 55 SE DECISION MADE: 31-AUG-23
Maastricht NL 6229 EV 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MONTAGE Settable, Resorbable Hemostatic Bone Putty
Orthocon, Inc. 510(k) NO: K213418(Traditional)
ATTN: Howard Schrayer PHONE NO : 914 3572600
1 Bridge Street, Suite 121 SE DECISION MADE: 30-AUG-23
Irvington NY 10533 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD Vacutainer K2EDTA Blood Collection Tubes, BD Vacutainer K3EDTA Blood Collection Tubes
Becton Dickinson and Company 510(k) NO: K213670(Traditional)
ATTN: Katherine Kenner Lemus PHONE NO : 801 5419274
1 Becton Drive SE DECISION MADE: 25-AUG-23
Franklin Lakes NJ 07417 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Alinity h-series System
Abbott Laboratories 510(k) NO: K220031(Traditional)
ATTN: Neha Vatsyayan PHONE NO : 408 3134401
4551 Great America Pkwy SE DECISION MADE: 04-AUG-23
Santa Clara CA 95054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit
KRONUS, Inc. 510(k) NO: K220085(Traditional)
ATTN: Delaney Sauer PHONE NO : 208 3774800
170 S. Seneca Springs Way Suite 10SE DECISION MADE: 24-AUG-23
Star ID 83669 510(k) STATEMENT
DEVICE: Monaghan medical filtered mouthpiece kit
Monaghan Medical Corporation 510(k) NO: K220145(Traditional)
ATTN: Cari J Reil PHONE NO : 518 5617330
153 Industrial Boulevard SE DECISION MADE: 24-AUG-23
Plattsburgh NY 12901 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Eco Abutment, Multiunit Abutment
DIO Corporation 510(k) NO: K220253(Traditional)
ATTN: Cho Hye-won PHONE NO : 82 51 7457836
66, Centumseo-ro SE DECISION MADE: 18-AUG-23
Busan KR 48058 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SQA-iO Sperm Quality Analyzer
Medical Electronic Systems LTD 510(k) NO: K220828(Traditional)
ATTN: Marcia Deutsch PHONE NO : 972 54 7708618
Alon Hatavor 20, Zone 6, Caesarea SE DECISION MADE: 07-AUG-23
Caesarea IL 3088900 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nova HD+
Aura Wellness, LLC 510(k) NO: K220938(Traditional)
ATTN: Scott Blomberg PHONE NO : 502 7141993
11530 Electron Drive SE DECISION MADE: 22-AUG-23
Louisville KY 40299 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Immunoglobulin G (IgG)
Beckman Coulter Laboratory Systems510(k) NO: K221114(Traditional)
ATTN: Tracy Jin PHONE NO : 86 512 68955129
No. 181 West Su Hong Road, Suzhou SE DECISION MADE: 02-AUG-23
Suzhou CN 215021 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Titus Titanium Cervical by SAGICO
SAGICO VA USA, LLC 510(k) NO: K221138(Traditional)
ATTN: James Gibson PHONE NO : 813 8150613
2189 W.Busch Blvd SE DECISION MADE: 04-AUG-23
Tampa FL 33612 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: circul™ pro Ring
BodiMetrics, LLC 510(k) NO: K221361(Traditional)
ATTN: Mark Goettling PHONE NO : 818 2686828
1601 N. Sepulveda Blvd, Suite 839 SE DECISION MADE: 29-AUG-23
Manhattan Beach CA 90266 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Lumbar Expandable lnterbody Spacers -Additional Indications/Implants
Globus Medical Inc. 510(k) NO: K221894(Traditional)
ATTN: Kelly Baker PHONE NO : 610 9301800
2560 General Armistead Ave. SE DECISION MADE: 03-AUG-23
Audubon PA 19403 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ID NOW COVID-19 2.0
Abbott Diagnostics Scarborough, In510(k) NO: K221925(Dual Track)
ATTN: Jessica E. Stahle PHONE NO : 207 7306353
10 Southgate Road SE DECISION MADE: 10-AUG-23
Scarborough ME 04074 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Q21
NeuroField Inc. 510(k) NO: K221959(Traditional)
ATTN: Nicholas J. Dogris PHONE NO : 760 8724200
386 West Lane SE DECISION MADE: 31-AUG-23
Bishop CA 93514 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nitrile Patient Examination Gloves, Powder Free, Pink Color
Shandong YINGHNG Medical Products 510(k) NO: K222103(Traditional)
ATTN: Emily Dong PHONE NO : 86 53 66136888
No.15 East Road, Hongrun Industry SE DECISION MADE: 24-AUG-23
Qingzhou CN 262500 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Protective Gown AAMI Level 4
Kenpax International Limited 510(k) NO: K222128(Traditional)
ATTN: Solomon Chen PHONE NO : 909 4387898
Flat 5, 5/F, Wing On Plaza, 62 ModSE DECISION MADE: 08-AUG-23
Hong Kong CN 999077 510(k) STATEMENT
DEVICE: HemoScreen Hematology Analyzer
PixCell Medical Technologies, Ltd.510(k) NO: K222148(Traditional)
ATTN: Yaara Ben Yosef PHONE NO : 972 4 9593516
6 Hayezira St. SE DECISION MADE: 16-AUG-23
Yoknaem Ilit IL 2069202 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACR Screw System
BioMaterials Korea, Inc 510(k) NO: K222245(Traditional)
ATTN: Young-yeop Kim PHONE NO : 82 31 7904511
#329, #331, #413 150, Jojeong-daerSE DECISION MADE: 21-AUG-23
Hanam-si KR 12930 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Atellica® CH Phencyclidine (Pcp), Atellica® CH Vancomycin (Vanc)
Siemens Healthcare Diagnostics Inc510(k) NO: K222439(Traditional)
ATTN: Joy Anoop PHONE NO : 516 2323307___
511 Benedict Avenue SE DECISION MADE: 08-AUG-23
Tarrytown NY 10591 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Air Smart Extra Spirometer
FeelLife Health Inc. 510(k) NO: K222443(Traditional)
ATTN: May Xiao PHONE NO : 0755 66867080
Room 1903, Building A, No.9 FurongSE DECISION MADE: 09-AUG-23
Shenzhen CN 518104 510(k) STATEMENT
DEVICE: Alveoair Digital Spirometer
Roundworks Technologies Private Li510(k) NO: K222525(Traditional)
ATTN: Prashant Patel PHONE NO : 91 750 7776273
Office No. B 302, Building No. B, SE DECISION MADE: 28-AUG-23
Wakad, Pune IN 411047 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD Kiestra IdentifA
Becton, Dickinson and Company 510(k) NO: K222563(Traditional)
ATTN: Laura Stewart PHONE NO : 410___ 5044252
7 Loveton Circle Mail Code 694 SE DECISION MADE: 31-AUG-23
Sparks MD 21152 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Premier Resolution System
Trinity Biotech (Primus Corporatio510(k) NO: K222635(Traditional)
ATTN: Kaitlyn Eastman PHONE NO : 716 4837423
4231 E. 75th Terrace SE DECISION MADE: 04-AUG-23
Kansas City MO 64132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Oral/Enteral Syringe with ENFit connector
Anhui Tiankang Medical Technology 510(k) NO: K222772(Traditional)
ATTN: Zhang Yong PHONE NO : 86 1370 5505106
No. 228, Weiyi Road, Economic DeveSE DECISION MADE: 17-AUG-23
Tianchang CN 239300 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Feeding Tube
Anhui Tiankang Medical Technology 510(k) NO: K222773(Traditional)
ATTN: Zhang Yong PHONE NO : 86 1370 5505106
No. 228, Weiyi Road, Economic DeveSE DECISION MADE: 17-AUG-23
Tianchang CN 239300 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 072 Aspiration System
Q’Apel Medical, Inc. 510(k) NO: K222786(Traditional)
ATTN: Kim Ky PHONE NO : 510 8284757
4245 Technology Drive SE DECISION MADE: 25-AUG-23
Fremont CA 94538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HAVAb IgG II
ABBOTT LABORATORIES 510(k) NO: K222850(Traditional)
ATTN: Dominic Tunzi PHONE NO : 224 6683644
100 Abbott Park Road SE DECISION MADE: 10-AUG-23
Abbott Park IL 60064 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BlueStar CGM insulin dose calculator
Welldoc, Inc. 510(k) NO: K222888(Traditional)
ATTN: Ian Cadieux PHONE NO : 619 8940873
10221 Wincopin Circle, Ste #150 SE DECISION MADE: 11-AUG-23
Columbia MD 21044 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Oneday Mini Implant System
Oneday Biotech Co., Ltd. 510(k) NO: K222946(Traditional)
ATTN: Jae Hyun Song PHONE NO : 82 53 5812835
135 C Seongseodongro Dalseogu SE DECISION MADE: 23-AUG-23
Daegu KR 42721 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BioProtect Balloon Implant™ System
BioProtect, Ltd. 510(k) NO: K222972(Traditional)
ATTN: Itay Barnea PHONE NO : 97 52 8677373
8 Tsor st SE DECISION MADE: 25-AUG-23
Tzur Yigal IL 4486200 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Flexylon Surgical Powder Free Gloves with Low Dermatitis Potential Claim, Green Tested For Use with 13 Chemotherapy Drugs; Flexylon Surgical Powder Free Gloves with Low Dermatitis Potential Claim, White Tested For Use with 32 Chemotherapy Drugs
Sentienx Sdn Bhd 510(k) NO: K222993(Traditional)
ATTN: Sahrudin Shah Bin Abu Bakar PHONE NO : 60 378 903338
Lot 7, Jalan Hi-Tech 12, Zon IndusSE DECISION MADE: 18-AUG-23
Kulim MY 09090 510(k) STATEMENT
DEVICE: Suture Anchors - HTA Headless Titanium Anchor and Zip Anchors
Gm Dos Reis Industria E Comerico L510(k) NO: K223114(Traditional)
ATTN: Iara Guimaraes PHONE NO : 55 19 37659900
Avenida Pierre Simon De La Place 6SE DECISION MADE: 02-AUG-23
Campinas BR 13069320 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MENIX®; MENIX® DUO
S.B.M. SAS (Science & Bio Material510(k) NO: K223122(Traditional)
ATTN: Anne Cospin-Latapie PHONE NO : 33 562 422101
ZI du Monge SE DECISION MADE: 03-AUG-23
Lourdes FR 65100 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Shiley™ Pediatric Oral/Nasal Endotracheal Tube with TaperGuard™ Cuff, Non DEHP (86125, 86130, 86135, 86140, 86145, 86150, 86155, 86160)
Covidien 510(k) NO: K223130(Traditional)
ATTN: Anila Tarte PHONE NO : 978 4966694
6135 Gunbarrel Avenue SE DECISION MADE: 30-AUG-23
Boulder CO 80301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VisiRad XR
Imidex Inc. 510(k) NO: K223133(Traditional)
ATTN: Kris Zeschin PHONE NO : 303 9022171___
3513 Brighton Blvd., Suites 456 7 SE DECISION MADE: 03-AUG-23
Denver CO 80216 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: APS Metal Plate & Screw System
A Plus Biotechnology Co., Ltd 510(k) NO: K223150(Traditional)
ATTN: Frank Hsu PHONE NO : 886 2 22499222 710
2F-2, No. 120, Qiaohe Rd., ZhongheSE DECISION MADE: 24-AUG-23
New Taipei City TW 23584 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sleepiz One+
Sleepiz AG 510(k) NO: K223163(Third Party - Traditional)
ATTN: Marta Stepien PHONE NO : 41 76 7837350___
Hornbachstrasse 23 SE DECISION MADE: 18-AUG-23
Zurich CH 8008 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: Spirair Nasal Septal Strap
Spirair, Inc. 510(k) NO: K223167(Traditional)
ATTN: James Kintzing PHONE NO : 703 9999462
6084 Monterey Hwy, 108 SE DECISION MADE: 17-AUG-23
San Jose CA 95138 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AIRAscore
AIRAmed GmbH 510(k) NO: K223180(Traditional)
ATTN: Maximilian Stalter PHONE NO : 49 7071 5393366
Konrad-Adenauer-Str. 13 SE DECISION MADE: 25-AUG-23
Tübingen DE 72072 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Spinery™ RF Ablation System
Axon Spine Medical System 510(k) NO: K223303(Traditional)
ATTN: Salvatore Accardo PHONE NO : 39 335 5300347
Via Lepanto 84 SE DECISION MADE: 30-AUG-23
Pompei IT 80045 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ochsner Connected Inhaler Sensor
Ochsner Clinic Foundation 510(k) NO: K223367(Traditional)
ATTN: Hakm Murad PHONE NO : 504 8427785
1514 Jefferson Hwy SE DECISION MADE: 30-AUG-23
New Orleans LA 70121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Citric Complete Liquid Citric Acid Concentrate
Nipro Renal Solutions USA, Corp. 510(k) NO: K223431(Traditional)
ATTN: Vincent DeGrandchamp PHONE NO : 267 6784390
509 Fishing Creek Road SE DECISION MADE: 04-AUG-23
Lewisberry PA 17339 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ArtiFascia
Nurami Medical Ltd. 510(k) NO: K223445(Traditional)
ATTN: Hannoch Marksheid PHONE NO : 972 74 7408822
Ha'Namal 36 SE DECISION MADE: 10-AUG-23
Haifa IL 3303203 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Otsuka Digital Feedback Device-RW
Otsuka America Pharmaceutical, Inc510(k) NO: K223463(Traditional)
ATTN: Nancy Teague PHONE NO : 240 6833560___
2440 Research Boulevard SE DECISION MADE: 11-AUG-23
Rockville MD 20850 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nexis® compressive screws
Novastep 510(k) NO: K223468(Abbreviated)
ATTN: Gilles Audic PHONE NO : 33 29 9338650
2, allée Jacques Frimot SE DECISION MADE: 30-AUG-23
Rennes FR 350000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: V-PRO maX 2 Low Temperature Sterilization System
Steris Corporation 510(k) NO: K223476(Traditional)
ATTN: Anthony Piotrkowski PHONE NO : 440 3927437___
5960 Heisley Rd SE DECISION MADE: 07-AUG-23
Mentor OH 44060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AQUAbase nX, AQUAbase nX HT
B. Braun Medical Inc. 510(k) NO: K223479(Traditional)
ATTN: Rushtin Chaklader PHONE NO : 610 5962789
901 Marcon Blvd SE DECISION MADE: 16-AUG-23
Allentown PA 18109 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SuperBall Meniscal Repair System
Arcuro Medical Ltd. 510(k) NO: K223500(Traditional)
ATTN: Lee Ranon PHONE NO : 972 72 2607000
17 Tchelet St. SE DECISION MADE: 10-AUG-23
Misgav IL 2017400 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CL-DP40 (Dr’s Light PRIME), CL-DP40 (Dr’s Light CHOICE)
Good Doctors Co., Ltd. 510(k) NO: K223507(Traditional)
ATTN: Heeseop Lim PHONE NO : 714 2025789
#208, B-Dong, 283 Bupyeong-Daero, SE DECISION MADE: 04-AUG-23
Incheon KR 21315 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Carex Hybrid Personal Lubricant
Karex Industries Sdn. Bhd. 510(k) NO: K223519(Abbreviated)
ATTN: Lai Peng Lim PHONE NO : 60 7 6881996
PTD 7906 & 7907, Taman Pontian JaySE DECISION MADE: 11-AUG-23
Pontian MY 82000 510(k) STATEMENT
DEVICE: ALLEVYN Ag+ Border Antimicrobial Silicone Gel Adhesive Composite Hydrocellular Foam Dressing, ALLEVYN Ag+ Border Sacrum Antimicrobial Silicone Gel Adhesive Composite Hydrocellular Foam Dressing, ALLEVYN Ag+ Surgical Antimicrobial Silicone Gel Adhesive Composite Hydrocellular Foam Dressing
Smith & Nephew Medical Limited 510(k) NO: K223526(Traditional)
ATTN: Hannah Sharp PHONE NO : 44 077 40531714
101 Hessle Road SE DECISION MADE: 18-AUG-23
Hull GB HU3 2BN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Little Wave Clik, Rogue XP, Little Wave XP, Spark
Ki Mobility LLC 510(k) NO: K223527(Traditional)
ATTN: Mark Murphy PHONE NO : 715 3036447
5201 Woodward Drive SE DECISION MADE: 31-AUG-23
Stevens Point WI 54481 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Little Wave Arc; Little Wave Flip
Ki Mobility LLC 510(k) NO: K223533(Traditional)
ATTN: Mark Murphy PHONE NO : 715 3036447 ______
5201 Woodward Drive SE DECISION MADE: 31-AUG-23
Stevens Point WI 54481 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Integrity Implant
Anika Therapeutics, Inc. 510(k) NO: K223538(Traditional)
ATTN: Wei Zhao PHONE NO : 978 8885948
32 Wiggins Ave. SE DECISION MADE: 17-AUG-23
Bedford MA 01730 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Dreem 3S
Beacon Biosignals, Inc. 510(k) NO: K223539(Traditional)
ATTN: Delphine Lemoine PHONE NO : 33 6 32047992
22 Boston Wharf Rd., 7th Floor, unSE DECISION MADE: 18-AUG-23
Boston MA 02210 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TubaVent Balloon Dilatation System
Spiggle & Theis Medizintechnik Gmb510(k) NO: K223542(Traditional)
ATTN: Claudia Winterschladen PHONE NO : 49 2206 908165
Burghof 4 SE DECISION MADE: 03-AUG-23
Overath DE 51491 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sterile Water for Inhalation in 1L Flexoval ® bottles.
Hometa Inc 510(k) NO: K223551(Traditional)
ATTN: Raza Mohammed PHONE NO : 443 5545486
300 Great Oaks Blvd, Suite 325 SE DECISION MADE: 03-AUG-23
Albany NY 12203 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Spine Planning (2.0), Elements Spine Planning, Elements Planning Spine
Brainlab AG 510(k) NO: K223553(Traditional)
ATTN: Sadwini Suresh PHONE NO : 49 8999 15680
Olof-Palme-Str.9 SE DECISION MADE: 02-AUG-23
Munich DE 81829 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Plato 17 Microcatheter
Scientia Vascular Inc 510(k) NO: K223560(Traditional)
ATTN: Max Alfonso PHONE NO : 888 3859016
3487 West 2100 South Suite 100 SE DECISION MADE: 21-AUG-23
West Valley City UT 84119 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Onera Sleep Test System (Onera STS)
Onera B.V. 510(k) NO: K223573(Traditional)
ATTN: Ruben de Francisco Martin PHONE NO : 31 0 403082177
Torenallee 42-54 SE DECISION MADE: 18-AUG-23
Eindhoven NL 5617BD 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IntelliVue Patient Monitor MX400 (866060), IntelliVue Patient Monitor MX450 (866062), IntelliVue Patient Monitor MX500 (866064), IntelliVue Patient Monitor MX550 (866066)
Philips Medizin Systeme Boeblingen510(k) NO: K223574(Traditional)
ATTN: Siegfried Breitling PHONE NO : 49 151 20044377
Hewlett-Packard-Strasse 2 SE DECISION MADE: 22-AUG-23
Boeblingen DE 71034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Pre-Filled Normal Saline Flush Syringe
Anhui Tianyang Pharmaceutical Co.,510(k) NO: K223584(Traditional)
ATTN: Zhang Shunlin PHONE NO : 86 158 05509075
46 Tiantong Road, Tianchang City, SE DECISION MADE: 12-AUG-23
Tianchang CN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Access Folate Assay
Beckman Coulter, Inc. 510(k) NO: K223590(Traditional)
ATTN: Dr. Kuljeet Kaur PHONE NO : 1 952 4651914___
1000 Lake Hazeline Drive SE DECISION MADE: 23-AUG-23
Chaska MN 55318 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 23andMe® Personal Genome Service® (PGS®) Cancer Predisposition Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants)
23andMe, Inc. 510(k) NO: K223597(Traditional)
ATTN: Marianna Frendo PHONE NO : 650 6869288
349 Oyster Point Blvd SE DECISION MADE: 31-AUG-23
South San Francisco CA 94080 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sterilization Wrap
Wuhan Zonsen Medical Products Co.,510(k) NO: K223600(Traditional)
ATTN: Linna Ye PHONE NO :
No 8 Jinchao Rd, Zhucheng Street SE DECISION MADE: 25-AUG-23
Wuhan CN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LifeShield™ Infusion Safety Software Suite
ICU Medical, Inc. 510(k) NO: K223606(Traditional)
ATTN: Pernell Abrantes PHONE NO : 224 7062229
600 N. Field Drive SE DECISION MADE: 24-AUG-23
Lake Forest IL 60045 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Plum Duo™ Infusion System
ICU Medical, Inc. 510(k) NO: K223607(Traditional)
ATTN: Yuliya Matlin PHONE NO : 224 7062419
600 N. Field Drive SE DECISION MADE: 24-AUG-23
Lake Forest IL 60045 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GEM Premier 7000 with IQM3
Instrumentation Laboratory Company510(k) NO: K223608(Traditional)
ATTN: Gabriella Erdosy PHONE NO : 781 8614571
180 Hartwell Road SE DECISION MADE: 10-AUG-23
Bedford MA 01730 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Rubicon™ Control Support Catheter (H749394323506A1)
Boston Scientific Corporation 510(k) NO: K223633(Traditional)
ATTN: Mary-Jo Foley PHONE NO : 353 0915 17427
One Scimed Place Maple Grove SE DECISION MADE: 08-AUG-23
Maple Grove MN 55311-1566 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VisAble.IO
TechsoMed 510(k) NO: K223639(Traditional)
ATTN: Dalia Dickman, PhD PHONE NO : 972 54 5595951
Meir Weisgal 2 SE DECISION MADE: 28-AUG-23
Rehovot IL 7654055 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SaintView
Inviz Corporation 510(k) NO: K223660(Traditional)
ATTN: Priscilla Chung PHONE NO : 714 2025789
307, Biomedical Components Center,SE DECISION MADE: 14-AUG-23
Gwangju KR 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Surgeon Controlled Arm
Levita Magnetics International Cor510(k) NO: K223673(Traditional)
ATTN: Alberto Rodriguez-Navarro, PHONE NO : 650 2410320
4055-A Campbell Avenue SE DECISION MADE: 04-AUG-23
Menlo Park CA 94025 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Needle Guides and Grids
Advance Medical Designs, Inc. 510(k) NO: K223689(Traditional)
ATTN: David Mackie PHONE NO : 1 770 4223125 244
1241 Atlanta Industrial Drive SE DECISION MADE: 02-AUG-23
Marietta GA 30066 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Kyphoplasty Balloon Catheter
Jiangsu Changmei Medtech Co., Ltd.510(k) NO: K223709(Traditional)
ATTN: Yang Lifan PHONE NO : 86 186 51969542
No.27, Xinke West Road, Luoyang ToSE DECISION MADE: 16-AUG-23
Changzhou CN 213104 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ANNE One
Sibel Health Inc. 510(k) NO: K223711(Traditional)
ATTN: Sarah Coughlin PHONE NO : 224 2518859
6650 W Touhy Ave. SE DECISION MADE: 10-AUG-23
Niles IL 60714 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Powder Free Nitrile Examination Glove (Grey) Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
Better Care Plastic Technology Co.510(k) NO: K223713(Traditional)
ATTN: Zhu Chunyan PHONE NO : 86 311 66766067
Fuqian Xi Road, West district of SSE DECISION MADE: 07-AUG-23
Shenze County CN 050000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Lavieen
Won Tech Co., Ltd. 510(k) NO: K223727(Traditional)
ATTN: Hyun Sik Yoon PHONE NO : 82 10 67505346
64 Techno 8-ro SE DECISION MADE: 25-AUG-23
Yuseong-gu KR 34028 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ECGenius System
Cath Vision ApS 510(k) NO: K223787(Traditional)
ATTN: Mads Matthiesen PHONE NO : 45 31 470730
Titangade 11 SE DECISION MADE: 04-AUG-23
Copenhagen N DK 2200 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Reusable Temperature Probe, Disposable Temperature Probe
Shenzhen SINO-K Medical Technology510(k) NO: K223807(Traditional)
ATTN: Lao Chengxin PHONE NO : 86 137 15333326
Room401,Bldg2, Veteran Ind.City,GoSE DECISION MADE: 25-AUG-23
Shenzhen CN 518115 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Aveta System 2.0
Meditrina, Inc. 510(k) NO: K223813(Traditional)
ATTN: Csaba Truckai PHONE NO : 408 4714877
1190 Saratoga Avenue, Suite 180 SE DECISION MADE: 21-AUG-23
San Jose CA 95129 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Self-Cath Closed System
Coloplast 510(k) NO: K223821(Traditional)
ATTN: Preeti Jain PHONE NO : 612 4135614___
1601 West River Road North SE DECISION MADE: 02-AUG-23
Minneapolis MN 55411 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: eRapid Nebulizer System
PARI Respiratory Equipment, Inc. 510(k) NO: K223840(Traditional)
ATTN: Michael Judge PHONE NO : 804 2537274
2412 Pari Way SE DECISION MADE: 11-AUG-23
Midlothian VA 23112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NuEra Tight RF Family
BIOS s.r.l. 510(k) NO: K223856(Traditional)
ATTN: Manuela Brambilla PHONE NO : 0039 02 27304275
Via Guido Rossa 10/12 SE DECISION MADE: 11-AUG-23
Vimodrone IT 20055 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IDS ACTH II
Immunodiagnostic Systems Limited 510(k) NO: K223867(Traditional)
ATTN: Mick Henderson PHONE NO : 44 191___ 5190660
10 Didcot Way, Boldon Business PaSE DECISION MADE: 18-AUG-23
Boldon GB NE35 9PD 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BAROguard
Paragonix Technologies 510(k) NO: K223874(Traditional)
ATTN: Nathan Yetton PHONE NO : 1 617 8177790
Suite 408, 639 Granite St. SE DECISION MADE: 15-AUG-23
Braintree MA 02184 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Daye Tampon
Annes Daye Ltd 510(k) NO: K223883(Traditional)
ATTN: Valentina Milanova PHONE NO : 447 366 456294
The Biscuit Factory, 100 Drummond SE DECISION MADE: 18-AUG-23
London GB SE16 4DG 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VitalFlowTM Centrifugal Pump
Michigan Critical Care Consultants510(k) NO: K223898(Traditional)
ATTN: Martha Rumford PHONE NO : 734 9959089
2555 Bishop Circle West SE DECISION MADE: 25-AUG-23
Dexter MI 48130 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: InterCollagen® Guide
SigmaGraft Inc. 510(k) NO: K223912(Traditional)
ATTN: Elcin Chang PHONE NO : 1 714 5250112
575 Sally Place SE DECISION MADE: 17-AUG-23
Fullerton CA 92831 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SOMNUM (V.1.1.2.)
Honeynaps Co., Ltd 510(k) NO: K223922(Traditional)
ATTN: Tony Lee PHONE NO : 82 108 9220937
4F, Marine Tech B/D, 529, NonhyeonSE DECISION MADE: 16-AUG-23
Seoul KR 06126 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LW Implant System
Ossvis Co., Ltd. 510(k) NO: K223924(Traditional)
ATTN: Young Jae Kim PHONE NO : 82 31 3600082
7F and B1, 38, Burim-ro 170beon-giSE DECISION MADE: 08-AUG-23
Anyang-si KR 14055 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Silk'n Titan Allways
Silk'n Beauty Ltd. 510(k) NO: K230013(Traditional)
ATTN: Amit Goren PHONE NO : 972 4 9097470
Tabor Building, Shaar Yokneam SE DECISION MADE: 30-AUG-23
Yoqneam Illit IL 2069200 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MagVenture Pain Therapy: MagPro R30, MagPro R30 with MagOption, MagPro X100, MagPro X100 with MagOption
Tonica Elektronik A/S 510(k) NO: K230014(Traditional)
ATTN: Jan Kjøller PHONE NO : 45 2 4899976
Lucernemarken 15 SE DECISION MADE: 25-AUG-23
Farum DK DK-3520 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs and Low Dermatitis Potential
Ansell Healthcare Products, LLC. 510(k) NO: K230079(Traditional)
ATTN: Don Cronk PHONE NO : 775 4707106
2301 Robb Drive SE DECISION MADE: 23-AUG-23
Reno NV 89523 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Responsive Arthroscopy Stealth and Mini Stealth All-Suture Anchors
Responsive Arthroscopy LLC 510(k) NO: K230094(Traditional)
ATTN: Garrett Ahlborg PHONE NO : 612 5326800
701 N. 3rd Street, Suite 208 SE DECISION MADE: 25-AUG-23
Minneapolis MN 55401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Dentis s-Clean Regular Abutment
Dentis Co., Ltd 510(k) NO: K230126(Traditional)
ATTN: Gyu Ri Kim PHONE NO : 82 53 5893541
99, Seongseoseo-ro, Dalseo-gu SE DECISION MADE: 04-AUG-23
Daegu KR 42718 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Mick Valencia Applicator Set
Mick Radio-Nuclear Instruments, In510(k) NO: K230155(Traditional)
ATTN: James Hurlman PHONE NO : 914 6670291
521 Homestead Avenue SE DECISION MADE: 30-AUG-23
Mount Vernon NY 10550 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SoundBite® Crossing System XS Peripheral
Soundbite Medical Solutions, Inc. 510(k) NO: K230159(Traditional)
ATTN: Diane Marceau PHONE NO : 514 9562525 3352
2300 Alfred Nobel, Suite 230 SE DECISION MADE: 28-AUG-23
Montreal CA H4S 2A4 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: uCT 760 with uWS-CT-Dual Energy Analysis, uCT 780 with uWS-CT-Dual Energy Analysis
Shanghai United Imaging Healthcare510(k) NO: K230162(Traditional)
ATTN: Xin Gao PHONE NO : 86 21670 768885386
No. 2258 Chengbei Rd., Jiading IndSE DECISION MADE: 01-AUG-23
Shanghai CN 201807 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Luja Coudé (20118 Male CH8 - small packaging (Pocket size)), Luja Coudé (20111 Male CH10 - small packaging (Pocket size)), Luja Coudé (20112 Male CH12 - small packaging (Pocket size)), Luja Coudé (20114 Male CH14 - small packaging (Pocket size)), Luja Coudé (20101 Male CH10 - large packaging), Luja Coudé (20102 Male CH12 - large packaging), Luja Coudé (20104 Male CH14 - large packaging), Luja Coudé (20106 Male CH16 - large packaging)
Coloplast 510(k) NO: K230165(Traditional)
ATTN: Troy Thome PHONE NO : 612 3569917
1601 West River Road North SE DECISION MADE: 25-AUG-23
Minneapolis MN 55411 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Pulse Oximeter
Beijing Choice Electronic Technolo510(k) NO: K230172(Traditional)
ATTN: Haiying Zhao PHONE NO : 86 10 88794631
No. 9 Shuangyuan road, Badachu Hi-SE DECISION MADE: 12-AUG-23
Beijing CN 100041 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QDOSE® Multi-purpose Voxel Dosimetry (Personalized Dosimetry in Molecular Radiotherapy)
Versant Medical Physics and Radiat510(k) NO: K230221(Traditional)
ATTN: Darrell R. Fisher PHONE NO : 509 5393223___
119 N. Church Street SE DECISION MADE: 28-AUG-23
Kalamazoo MI 49007 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZenPro 40
Bluecore Company Co Ltd 510(k) NO: K230268(Traditional)
ATTN: Bill Choi PHONE NO : 82 517 474318
Ace Hightech 21 #1203 48, Centurm SE DECISION MADE: 10-AUG-23
Busan KR 48059 510(k) STATEMENT
DEVICE: PMT Expandable Cage (PMT EXP)
Providence Medical Technology, Inc510(k) NO: K230297(Traditional)
ATTN: Edward Liou PHONE NO : 415 9239376
4234 Hacienda Drive, Suite 150 SE DECISION MADE: 11-AUG-23
Pleasanton CA 94588 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Celsi Monitor
Hadleigh Health Technologies 510(k) NO: K230298(Traditional)
ATTN: Molly McCabe PHONE NO : 510 6733653
30 Castro Avenue SE DECISION MADE: 16-AUG-23
San Rafael CA 94901 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Polyisoprene Surgical Gloves
Puyang Linshi Medical Supplies Co.510(k) NO: K230304(Traditional)
ATTN: Catherine Liu PHONE NO : 86 198 39327898
East of Panjin Road and North of FSE DECISION MADE: 09-AUG-23
Puyang CN 457001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sterile Powder Free Nitrile Examination Gloves (Blue, Black &White Colors)
New Era Medicare Sdn. Bhd. 510(k) NO: K230314(Traditional)
ATTN: Fatin Nor Irdina binti AhmadPHONE NO : 60 149 072860
Plot 2621-2624 SE DECISION MADE: 16-AUG-23
Teluk Intan MY 36000 510(k) STATEMENT
DEVICE: Phototherapy System (OL-PDT950)
Shanghai Omni Laser Skinology Co.,510(k) NO: K230342(Traditional)
ATTN: Avril Ouyang PHONE NO : 86 021 54847192
Floor 3, Building 3, NO.227, MingqSE DECISION MADE: 16-AUG-23
Shanghai CN 201612 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vantage Galan 3T, MRT-3020, V9.0 with AiCE Reconstruction Processing Unit for MR
Canon Medical Systems Corporation 510(k) NO: K230355(Traditional)
ATTN: Janine F Reyes PHONE NO : 714 6697853
1385 Shimoshigami SE DECISION MADE: 30-AUG-23
Otawara-shi JP 324-8550 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VitalFlow™ Console
Michigan Critical Care Consultants510(k) NO: K230364(Traditional)
ATTN: Martha Rumford PHONE NO : 734 9959089
2555 Bishop Circle West SE DECISION MADE: 25-AUG-23
Dexter MI 48130 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Reprocessed Agilis NxT Steerable Introducer
Innovative Health, LLC. 510(k) NO: K230376(Traditional)
ATTN: Rick Ferreira PHONE NO : 877 4003740
1435 North Hayden Road, Suite 100 SE DECISION MADE: 07-AUG-23
Scottsdale AZ 85257 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Surgical Face Masks, Model: EFMDS-L50Pn BLU
Iris USA 510(k) NO: K230380(Traditional)
ATTN: Michael Cruz PHONE NO : 602 7071770
11111 80th Ave. SE DECISION MADE: 03-AUG-23
Pleasant Prairie WI 53158 510(k) STATEMENT
DEVICE: PolyWear® Personal Protective Level 3 Gown
Polyconversions, INC 510(k) NO: K230384(Traditional)
ATTN: William Smith PHONE NO : 309 6623614
3202 Apollo Drive SE DECISION MADE: 11-AUG-23
Champaign IL 61822 510(k) STATEMENT
DEVICE: Wrist Type Blood Pressure Monitor (W05,W1101L)
Shenzhen Jamr Technology Co., Ltd.510(k) NO: K230409(Traditional)
ATTN: Haiyu Zhang PHONE NO : 86 186 75539961
A101-301, D101-201, Jamr Science &SE DECISION MADE: 25-AUG-23
Shenzhen CN 518100 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cadwell Guardian
Cadwell Industries, Inc. 510(k) NO: K230415(Traditional)
ATTN: Jason Ford PHONE NO : 509 7356481
909 North Kellogg Street SE DECISION MADE: 17-AUG-23
Kennewick WA 99336 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sequel Tampon with Plastic Applicator
Tampro Inc 510(k) NO: K230419(Traditional)
ATTN: Greta Meyer PHONE NO : 215 2609081
3749 Buchanan Street #316 SE DECISION MADE: 03-AUG-23
San Fransisco CA 94123 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Dr. pen Microneedling System
Guangzhou Ekai Electronic Technolo510(k) NO: K230420(Traditional)
ATTN: Guihua Chen PHONE NO : 86 020 81177539
3/F Building E No.81 Zijing Road, SE DECISION MADE: 11-AUG-23
Guangzhou CN 510000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ambu® aScope™ 5 Broncho 2.7/1.2, Ambu® aScope™ 5 Broncho 4.2/2.2, Ambu® aBox™ 2
Ambu A/S 510(k) NO: K230428(Traditional)
ATTN: Karina Matthiesen PHONE NO : 45 7225 2094
Baltorpbakken 13 SE DECISION MADE: 10-AUG-23
Ballerup DK 2750 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sterile Syringe Bulk Tray
Shanghai Kindly Enterprise Develop510(k) NO: K230447(Traditional)
ATTN: Hualong Liu PHONE NO : 86 02169 118232
No.658 Gaochao Road SE DECISION MADE: 16-AUG-23
Shanghai CN 201803 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cove Strip
SeaSpine Orthopedics Corporation 510(k) NO: K230486(Traditional)
ATTN: Cindy Toyama PHONE NO : 949 8557175
2 Goodyear SE DECISION MADE: 21-AUG-23
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EL27-Compact; Sterile EHL-Probes
Walz Elektronik GmbH 510(k) NO: K230488(Traditional)
ATTN: Bernd Vollmer PHONE NO : 49 745 22020
Walddorfer Strasse 40 SE DECISION MADE: 31-AUG-23
Rohrdorf DE 72229 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Visual-ICE Cryoablation System
Boston Scientific Corporation 510(k) NO: K230551(Traditional)
ATTN: Amy McKinney PHONE NO : 651 2875096
One Scimed Place SE DECISION MADE: 08-AUG-23
Maple Grove MN 55311-1566 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Arm-type Fully Automatic Digital Blood Pressure Monitor, Wrist-type Fully Automatic Digital Blood Pressure Monitor
Joytech Healthcare Co.,Ltd 510(k) NO: K230566(Traditional)
ATTN: Ren Yunhua PHONE NO : 86 571 81957767
No.365, Wuzhou Road Yuhang EconomiSE DECISION MADE: 25-AUG-23
Hangzhou CN 311100 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sterile Triplex Surgical Gown (S, M, L, XL, XXL, XXXL)
Medcare Saglik Urunleri Sanayi Ve 510(k) NO: K230577(Traditional)
ATTN: Muge Ersahin PHONE NO : 90 232 28116
Fatih Mah. Camlik Cad No 54 SE DECISION MADE: 16-AUG-23
Izmir TR 35410 510(k) STATEMENT
DEVICE: Polyisoprene Surgical Glove (Unified Double Layer), Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl
WRP Asia Pacific Sdn. Bhd. 510(k) NO: K230578(Traditional)
ATTN: Saravanan Ramasamy PHONE NO : 60 387 061486
Lot 1, Jalan 3, Kawasan PerusahaanSE DECISION MADE: 31-AUG-23
Sepang MY 43900 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Smart Wedge algorithm
Edwards Lifesciences, LLC 510(k) NO: K230579(Traditional)
ATTN: Jennifer Wilbur PHONE NO : 949 7564436
1 Edwards Way SE DECISION MADE: 18-AUG-23
Irvine CA 92614 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TOPA12 Portable X-ray Unit
NEUF Inc. 510(k) NO: K230581(Traditional)
ATTN: Woo Sang Lee PHONE NO : 82 61 7402830
#103 Production Bldg. 13, YulchonsSE DECISION MADE: 16-AUG-23
Suncheon-si KR 58034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Aer-O-Scope Colonoscope System
GI View Ltd. 510(k) NO: K230588(Traditional)
ATTN: Sharon Goldfarb PHONE NO : 972 54 6454034
5 Shoham St. SE DECISION MADE: 17-AUG-23
Ramat Gan IL 5251001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Arrow Non-Stimulating SnapLock Adapter (K-05520-005C); Arrow Non-Stimulating Next Gen SnapLock Adapter (Luer Connection) (CA-000010-19); Arrow Non-Stimulating Next Gen SnapLock Adapter (Neuraxial Connection) (CA-000014-19); Arrow Stimulating SnapLock Adapter (with cable) (TZ-02060-001); Arrow Stimulating SnapLock Adapter (with tab) (TZ-05000-002)
Teleflex Medical 510(k) NO: K230603(Traditional)
ATTN: Kristen Bisanz PHONE NO : 404 2909807
3015 Carrington Mill Blvd. SE DECISION MADE: 30-AUG-23
Morrisville NC 27560 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPICCA Cervical Fusion Cages
Southern Medical (Pty) Ltd 510(k) NO: K230607(Traditional)
ATTN: Nathan Wright PHONE NO : 719 3510248
Building 10, Southern Implants OffSE DECISION MADE: 14-AUG-23
Irene ZA 0062 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPICCA Stand-Alone Cervical Fusion Cages
Southern Medical (Pty) Ltd 510(k) NO: K230608(Traditional)
ATTN: Dalene Styger PHONE NO : 27 12 6676243
55 Regency Drive Route 21 CorporatSE DECISION MADE: 14-AUG-23
Irene ZA 0178 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Surgical Gown (Level 3, MF2103 Series), Disposable Surgical Gown (Level 3, MF2104 Series), Disposable Surgical Gown (Level 4, MF2105 Series)
Dongguan Shin Yi Healthcare Produc510(k) NO: K230610(Traditional)
ATTN: Shuge Zhao PHONE NO : 86 769 8336138
No. 17 Ban Hu Road, Huang Jiang ToSE DECISION MADE: 23-AUG-23
Dong Guan CN 523750 510(k) STATEMENT
DEVICE: SKEEPER
Smartsound Corporation 510(k) NO: K230613(Traditional)
ATTN: Jungho Lee PHONE NO : 82 257 52252
171, Yangjaecheon-ro, Gangnam-gu SE DECISION MADE: 02-AUG-23
Seoul KR 06302 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging Catheter
Gentuity, LLC 510(k) NO: K230620(Traditional)
ATTN: Padmini Gagnon PHONE NO : 508 4251560
142 North Road, Suite G SE DECISION MADE: 08-AUG-23
Sudbury MA 01776 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ReliOn Premier BLU Blood Glucose Monitoring System
i-SENS, Inc. 510(k) NO: K230625(Special)
ATTN: H.S. Yoo PHONE NO : 82 29 100516
43, Banpo-Daero 28 Gil Seocho-Gu SE DECISION MADE: 10-AUG-23
Seoul KR 06646 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Portrait™ Central Viewer Application (Portrait CV A01), Portrait ™ Core Services (Portrait CSS01), Portrait™ Clinical Alarming Unit (Portrait CAU01); Portrait™ Mobile Patient Monitor (Portrait HUB01), Portrait™ Sensor Battery (Portrait SBT01), Portrait™ Bedside Charger (Portrait BCH01); Portrait™ Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SA01, Portrait SpO2 P-SP01, Portrait SpO2 P-W01 and Portrait SpO2 P-SE01); Portrait™ SpO2 Attachment Accessory Band (Portrait AAB01), Portrait™ Mobile Patient Monitor Pouch (Portrait MMP01); Portrait™ Wearable Respiration Rate Sensor (Portrait RR P-RR01), Portrait™ RR Electrode Patch (Portrait RRP01)
GE Medical Systems Information Tec510(k) NO: K230626(Traditional)
ATTN: Joel Kent PHONE NO : 617 8510943
9900 Innovation Drive SE DECISION MADE: 11-AUG-23
Wauwatosa WI 53226 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VersiHD with GuideMe software
NxStage Medical, Inc. 510(k) NO: K230632(Traditional)
ATTN: Denise Oppermann PHONE NO : 781 9969103
350 Merrimack St. SE DECISION MADE: 11-AUG-23
Lawrence MA 01843 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Electronic Blood Pressure Monitor
Dongguan kangweile Electronic Tech510(k) NO: K230642(Traditional)
ATTN: Zhixin Gao PHONE NO : 86 769 82677482
4th floor, building D, Yizhong SciSE DECISION MADE: 11-AUG-23
Dongguan CN 523770 510(k) STATEMENT
DEVICE: Density
Jeisys Medical Inc. 510(k) NO: K230663(Traditional)
ATTN: Bora Kim PHONE NO : 82 10 30197221
307 Daeryung Techno Town 8th SE DECISION MADE: 14-AUG-23
Seoul KR 08501 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Annabella Breast Pump
Annabella Ltd. 510(k) NO: K230672(Traditional)
ATTN: Uri Yaffe PHONE NO : 97 254 5555484
23/5 Hataas SE DECISION MADE: 04-AUG-23
KFAR SABA IL 4442525 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Tandry Locking Plate System
Microware Precision Co., Ltd. 510(k) NO: K230690(Traditional)
ATTN: Harrison Du PHONE NO : 886 4 24636275 100
No. 12, Keyuan 2nd Rd., Situn DistSE DECISION MADE: 17-AUG-23
Taichung TW 40763 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Stryker Resorbable Fixation System
Stryker Leibinger GmbH & Co. KG 510(k) NO: K230733(Traditional)
ATTN: Gregory Gohl PHONE NO : 269 3701476
Boetzinger Strasse 41 SE DECISION MADE: 05-AUG-23
Freiburg DE D-79111 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Ureteral Access Sheath
YouCare Technology Co., Ltd. (Wuha510(k) NO: K230748(Traditional)
ATTN: Bing Hu PHONE NO : 86 27 87926396 830___
Tangxunhu North Street SE DECISION MADE: 02-AUG-23
Wuhan CN 430000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TK Pre-Filled Normal Saline Flush Syringe
Anhui Tiankang Medical Technology 510(k) NO: K230756(Traditional)
ATTN: Bai Baodong PHONE NO : 86 1350 5557811
No. 228 Weiyi Road, Economic DevelSE DECISION MADE: 12-AUG-23
Tianchang CN 510(k) STATEMENT
DEVICE: Precice Ankle Salvage System
NuVasive Specialized Orthopedics, 510(k) NO: K230765(Traditional)
ATTN: Miriam Cervantes PHONE NO : 909 2297836
101 Enterprise, Suite 100 SE DECISION MADE: 29-AUG-23
Aliso Viejo CA 92656 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Withings Scan Monitor 2.0
Withings 510(k) NO: K230812(Traditional)
ATTN: Khushboo Surendran PHONE NO : 857 2052072
2 rue Maurice Hartmann SE DECISION MADE: 23-AUG-23
Issy-Les-Moulineaux FR 92130 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Powdered Free Sterile Natural Rubber Latex Surgical Gloves
The Egyptian Company For Medical &510(k) NO: K230832(Traditional)
ATTN: Alaa Elsayed PHONE NO : 201 0000 80163
Industrial Zone 7. Part 7062A&B SE DECISION MADE: 16-AUG-23
Sadat City EG 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EXTRON 5; EXTRON 7
DRTECH Corporation 510(k) NO: K230871(Traditional)
ATTN: Kim Minjeong PHONE NO : 82 031 7797783
Suite No. 1, 2 Floor/Suite No. 2, SE DECISION MADE: 17-AUG-23
Seongnam-si KR 13216 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Angulated Screw Channel (ASC) Solution Abutments & SI-BASE Abutments
Southern Implants (Pty) Ltd 510(k) NO: K230873(Traditional)
ATTN: Colin Saffy PHONE NO : 27 12 6671046
1 Albert Road SE DECISION MADE: 01-AUG-23
Irene ZA 0062 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: qXR-PTX-PE
Qure.ai Technologies 510(k) NO: K230899(Traditional)
ATTN: Ayushi Mahendra PHONE NO : 91 22 68505800
Level 7, Commerz II, InternationalSE DECISION MADE: 22-AUG-23
Mumbai IN 400063 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vein360 Reprocessed Visions PV.018 Digital IVUS Catheter
Vein 360 LLC 510(k) NO: K230928(Traditional)
ATTN: Suzanne Meyer PHONE NO : 513 5541300
4460 Lake Forest Dr Suite 230 SE DECISION MADE: 25-AUG-23
Blue Ash OH 452423741 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Arthrex Radiopaque FiberTape Cerclage sutures
Arthrex, Inc 510(k) NO: K230976(Traditional)
ATTN: Stacy Valdez PHONE NO : 1 239 6435553 72010
1370 Creekside Boulevard SE DECISION MADE: 24-AUG-23
Naples FL 34108-1945 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Yomi Robotic System
Neocis Inc. 510(k) NO: K231018(Traditional)
ATTN: Joshua Davis PHONE NO : 508 2940749
2800 Biscayne Blvd Suite 600 SE DECISION MADE: 14-AUG-23
Miami FL 33137 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AquaBeam Robotic System
PROCEPT BioRobotics Corporation 510(k) NO: K231024(Traditional)
ATTN: Sara Muddell PHONE NO : 650 2327217
900 Island Drive, Suite 101 SE DECISION MADE: 30-AUG-23
Redwood City CA 94065 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 12MP Color LCD Monitor C1216W, C12*** ("*" = 0 to 9, A to Z or blank, and the difference among models means the product is named according to different appearance colors and customer models)
Shenzhen Beacon Display Technology510(k) NO: K231026(Traditional)
ATTN: Li Yafei PHONE NO : 86 248 8087610
15F, Building 6, Hengda Shishang HSE DECISION MADE: 18-AUG-23
Shenzhen CN 518109 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Unicare (K-UNICARE-USA)
TensCare Ltd 510(k) NO: K231053(Traditional)
ATTN: Saskia Eldridge-Hinmers PHONE NO : 44 137 2723434
9 Blenheim Road SE DECISION MADE: 18-AUG-23
Epsom GB KT199BE 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: V-Laser
WON TECH Co., Ltd. 510(k) NO: K231054(Special)
ATTN: Hyun Sik Yoon PHONE NO : 82 10 67505346
64 Techno 8-ro, Yuseong-gu SE DECISION MADE: 14-AUG-23
Daejeon KR 34028 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 1.5T HD T/R Knee Array (10-F34127)
Shenzhen RF Tech Co., Ltd. 510(k) NO: K231085(Traditional)
ATTN: Wang Gary PHONE NO : 0086__ 7552 6641989
2-F,BLD4 Juhui Industrial Park,TiaSE DECISION MADE: 18-AUG-23
Shenzhen CN 518132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Guided Surgery Kit
Implant Direct Sybron Manufacturin510(k) NO: K231087(Traditional)
ATTN: Reina Choi PHONE NO : 1 818 3073132
3050 East Hillcrest Drive SE DECISION MADE: 16-AUG-23
Thousand Oaks CA 91362 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AlphaVent Suture Anchors
Stryker Endoscopy 510(k) NO: K231093(Traditional)
ATTN: Katie Farraro PHONE NO : 408___ 4647396
5900 Optical Ct. SE DECISION MADE: 30-AUG-23
San Jose CA 95138 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Annalise Enterprise CTB Triage-OH
Annalise-AI Pty Ltd 510(k) NO: K231094(Traditional)
ATTN: Haylee Bosshard PHONE NO : 61 4932 66602
Level P, 24 Campbell St. SE DECISION MADE: 15-AUG-23
Sydney AU 2000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Automatic Continuous Effusion Shunt (ACES) System ACES System
Pleural Dynamics, Inc. 510(k) NO: K231096(Traditional)
ATTN: Martin Mayse PHONE NO : 314 5181786
952 Medina Road SE DECISION MADE: 18-AUG-23
Wayzata MN 55391 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LineSider® Spinal System
Integrity Implants Inc. 510(k) NO: K231098(Traditional)
ATTN: Alexa Kamer PHONE NO : 561 5293861
354 Hiatt Drive SE DECISION MADE: 07-AUG-23
Palm Beach Gardens FL 33418 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Zimmer® Natural Nail® System Cephalomedullary Nails; Affixus® Natural Nail® Humeral Nail System
Zimmer Switzerland Manufacturing G510(k) NO: K231114(Traditional)
ATTN: Annemie Kausch Rehor PHONE NO : 41 795 615986
Sulzerallee 8 SE DECISION MADE: 09-AUG-23
Winterthur CH 8404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Phoenix Contact Lens Case - dome top flat pack (CL-01); Phoenix Contact Lens Case - classic flat pack (CL-02); Phoenix Contact Lens Case - sunglass shape flat pack (CL-03)
Phoenix Innovative Healthcare Manu510(k) NO: K231123(Traditional)
ATTN: Michael Stuart PHONE NO : 954 8804274
EL-209, Shil Mahape Road ElectroniSE DECISION MADE: 30-AUG-23
Navi Mumbai IN 400710 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Eblator Device
E Surgical, LLC 510(k) NO: K231126(Traditional)
ATTN: Michael Blomeyer PHONE NO : 775___ 4331808___
150 Isidor Court Unit 203 SE DECISION MADE: 02-AUG-23
Sparks NV 89441 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Enzyme Packed Cartridge - RELiZORB
Alcresta Therapeutics, Inc. 510(k) NO: K231156(Traditional)
ATTN: Matthew King PHONE NO : 603 4599755
130 Turner Street, Building 3, SuiSE DECISION MADE: 30-AUG-23
Waltham MA 02453 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Conductive carbon film electrode
Guangzhou Xinbo Electronic Co., Lt510(k) NO: K231164(Traditional)
ATTN: Sammy Li PHONE NO : 86 020 34822409
No.23 Building, The Second Phase, SE DECISION MADE: 09-AUG-23
Guangzhou CN 511450 510(k) STATEMENT
DEVICE: Conductive Silicone Rubber Electrode
Guangzhou Xinbo Electronic Co., Lt510(k) NO: K231167(Traditional)
ATTN: Sammy Li PHONE NO : 86 020 34822409
No.23 Building, The Second Phase HSE DECISION MADE: 09-AUG-23
Guangzhou CN 511450 510(k) STATEMENT
DEVICE: BPBIO750
InBody Co, Ltd. 510(k) NO: K231174(Traditional)
ATTN: Kichul Cha PHONE NO : 82 02 5013939
15, Heugam-Gil , Ipjang-Myueon, SeSE DECISION MADE: 02-AUG-23
Cheonan-Si KR 31025 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Non absorbable Surgical Polyester Suture
Shandong Haidike Medical Products 510(k) NO: K231183(Traditional)
ATTN: Yan Wang PHONE NO : 86 530 4660062
Tianfu Road, Dongcheng District, SSE DECISION MADE: 25-AUG-23
Heze CN 274300 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cochlear™ Osia® System; Cochlear™ Osia® OSI300 Implant; Cochlear™ Magnet Cassette; Cochlear™ Non-Magnetic Cassette; Cochlear™ Osia® 2(I) Sound Processor; Cochlear™ Osia® Fitting Software 2; Cochlear™ Osia® Smart App
Cochlear 510(k) NO: K231204(Traditional)
ATTN: Denis DiMartino PHONE NO : 508 3044356
10350 Park Meadows Drive SE DECISION MADE: 18-AUG-23
Lone Tree CO 80124 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GuruNanda Dry Mouth Oral Rinse and GuruNanda Dry Mouth Oral Spray
GuruNanda LLC 510(k) NO: K231205(Traditional)
ATTN: Puneet Nanda PHONE NO : 714 4100466
6645 Caballero Blvd. SE DECISION MADE: 22-AUG-23
Buena Park CA 90620 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Stryker Resorbable Fixation System
Stryker Leibinger GmbH & Co. KG 510(k) NO: K231208(Traditional)
ATTN: Gregory Gohl PHONE NO : 269 3701476
Boetzinger Strasse 41 D-79111 SE DECISION MADE: 14-AUG-23
Freiburg DE 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ventrax™ Delivery System (VTR851)
Merit Medical Systems, Inc. 510(k) NO: K231246(Traditional)
ATTN: Jenny Soderquist PHONE NO : 801 2084579
1600 West Merit Parkway SE DECISION MADE: 30-AUG-23
South Jordan UT 84095 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NovoFine® Plus
Novo Nordisk Inc. 510(k) NO: K231255(Special)
ATTN: Hiral Palkhiwala Shah PHONE NO : 609 7877603
P.O Box 846 SE DECISION MADE: 25-AUG-23
Plainsboro NJ 08536 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Pangea Utility Plating System, Pangea Platform
Stryker GmbH 510(k) NO: K231257(Traditional)
ATTN: Danese Joiner-Fox PHONE NO : 475 3334452
325 Corporate Drive SE DECISION MADE: 18-AUG-23
Mahwah NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System, Pangea Humerus Plating System
Stryker GmbH 510(k) NO: K231262(Traditional)
ATTN: Danese Joiner-Fox PHONE NO : 475 3334452
325 Corporate Drive SE DECISION MADE: 18-AUG-23
Mahwah NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Pediatric Nailing Platform | Tibia
OrthoPediatrics Corp. 510(k) NO: K231266(Traditional)
ATTN: Yan Li PHONE NO : 574 2670864
2850 Frontier Drive SE DECISION MADE: 21-AUG-23
Warsaw IN 46582 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Natural Cycles
Natural Cycles Nordic AB 510(k) NO: K231274(Traditional)
ATTN: Raoul Scherwitzl, PhD PHONE NO : 46 707 174866____
St Eriksgatan 63b SE DECISION MADE: 24-AUG-23
Stockholm SE 112 34 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SmartCardia 7L Platform
SmartCardia SA 510(k) NO: K231276(Traditional)
ATTN: Srinivasan Murali PHONE NO : 41 788 750864
EPFL Innovation Park Building C SE DECISION MADE: 30-AUG-23
Lausanne CH 1015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Knotless Suture Anchor
Riverpoint Medical, LLC 510(k) NO: K231278(Traditional)
ATTN: Bianca Silva de Sousa PHONE NO : 503 5178001
815 NE 25th Ave SE DECISION MADE: 01-AUG-23
Portland OR 97232 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Chemfort® Catheter Adaptor
Simplivia Healthcare LTD. 510(k) NO: K231286(Traditional)
ATTN: Shay Shaham PHONE NO : 97 246 908826
North Industrial Zone SE DECISION MADE: 02-AUG-23
Kiryat Shmona IL 1101801 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: S-Patch Ex Wearable ECG Patch
Wellysis Corp. 510(k) NO: K231289(Traditional)
ATTN: DoGyun Im PHONE NO : 82 109 1408475
8F, 425 Teheran-ro, Gangnam-gu SE DECISION MADE: 30-AUG-23
Seoul KR 06159 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vscan Air
GE Medical Systems Ultrasound and 510(k) NO: K231301(Traditional)
ATTN: Bush Lee PHONE NO : 262 3099429
9900 W. Innovation Drive SE DECISION MADE: 15-AUG-23
Wauwatosa WI 53226 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ancora-SB
Aspero Medical, Inc. 510(k) NO: K231323(Traditional)
ATTN: Mark Rentschler PHONE NO : 303 8347885
320 E. Vine Drive, Suite 101 SE DECISION MADE: 31-AUG-23
Fort Collins CO 80524 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LUX-Dx II (M302); LUX-Dx II+ (M312)
Boston Scientific Corp 510(k) NO: K231328(Traditional)
ATTN: Melissa Klamerus PHONE NO : 651 5826771
4100 Hamline Ave North SE DECISION MADE: 19-AUG-23
St. Paul MN 55112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STRETTO™ Cable System
Globus Medical Inc. 510(k) NO: K231333(Traditional)
ATTN: Jennifer Antonacci PHONE NO : 610 9301800
2560 General Armistead Ave. SE DECISION MADE: 04-AUG-23
Audubon PA 19403 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Organic cotton tampon, Viscose tampon
Zhejiang Tianqing Manufacturing Te510(k) NO: K231341(Traditional)
ATTN: Roy Du PHONE NO : 86 138 17862379
Lianshi Industrial Park, Nanxun DiSE DECISION MADE: 14-AUG-23
Huzhou CN 313013 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ActivSight Intraoperative Imaging System
Activ Surgical Inc. 510(k) NO: K231344(Traditional)
ATTN: Nicholas Child PHONE NO : 857 4494840
30 Thomson Place SE DECISION MADE: 02-AUG-23
Boston MA 02110 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Dewin Blastocyst Medium (with HSA and without HSA)
DonneVie Medical Technology (Shang510(k) NO: K231370(Traditional)
ATTN: Hannah Hang Yin PHONE NO :
Suite 201, Bld 1, 138 Xinjun Ring SE DECISION MADE: 04-AUG-23
Shanghai CN 201114 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Q-FIX With Needles (Q-FIX With Needles, #0 Suture & Q-FIX With Needles, Minitape)
Smith & Nephew Inc. 510(k) NO: K231376(Traditional)
ATTN: Pragnya Bakka PHONE NO : 512 3913900
150 Minuteman Road SE DECISION MADE: 09-AUG-23
Andover MA 01810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AirLife DuoTherm™ Humidification System
Vyaire Medical, Inc. 510(k) NO: K231380(Traditional)
ATTN: Megan Walsh PHONE NO : 872 2063142
26125 N. Riverwoods Blvd. SE DECISION MADE: 10-AUG-23
Mettawa IL 60045 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Harvest Dental HD Gum Strip
Harvest Dental Products, LLC 510(k) NO: K231389(Traditional)
ATTN: Colleen Boswell PHONE NO : 714 5853431
905 Columbia Street SE DECISION MADE: 16-AUG-23
Brea CA 92821 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Intense Pulsed Light System
Smedtrum Medical Technology Co., L510(k) NO: K231394(Traditional)
ATTN: Crimson Wu PHONE NO : 88 622 2989578 301
1F., No. 8, Ln. 97, Wugong Rd., SE DECISION MADE: 09-AUG-23
New Taipei City TW 248016 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Bladeless Trocar – Artemis Lap Cannula
T.A.G. Medical Products Corporatio510(k) NO: K231400(Special)
ATTN: Shlomi Dines PHONE NO : 972 4 9858400
T.A.G. Medical Products CorporatioSE DECISION MADE: 04-AUG-23
Gaaton IL 2513000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: T-Button® A Adjustable Loop UHMWPE Suture PEEK Button, Close Button, T-Button® S Adjustable Loop UHMWPE Suture PEEK Button, Open Button
Healthium Medtech Limited 510(k) NO: K231404(Traditional)
ATTN: Pankaj Dawar PHONE NO : 91 988 6529934
472-D, 13th Cross, 4th Phase, PeenSE DECISION MADE: 04-AUG-23
Bangalore IN 560058 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: StarFin
Premium Medical Technology LLC 510(k) NO: K231407(Traditional)
ATTN: Kuowei Chang PHONE NO : 781 8914201
1377 Main Street 2nd Floor SE DECISION MADE: 29-AUG-23
Waltham MA 02451 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Basic Synguard Nitrile Exam Gloves, Powder Free, Blue Colored, Non-Sterile
Shandong Intco Medical Products Co510(k) NO: K231408(Traditional)
ATTN: Max Li PHONE NO : 86 189 18364816
No. 9888 Qiwang Road, Naoshan InduSE DECISION MADE: 11-AUG-23
Qingzhou CN 2625000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Erchonia FX-405
Erchonia Corporation 510(k) NO: K231409(Traditional)
ATTN: Travis Sammons PHONE NO : 888 2420571
650 Atlantis Road SE DECISION MADE: 11-AUG-23
Melbourne FL 32904 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EnSite™ X EP System
Abbott Medical 510(k) NO: K231415(Traditional)
ATTN: Alyssa Timmers PHONE NO : 651 7563706
One St. Jude Medical Drive SE DECISION MADE: 10-AUG-23
St. Paul MN 55117 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENDOGATOR™ Hybrid Irrigation Tubing
Medivators 510(k) NO: K231418(Traditional)
ATTN: Disha Kabrawala PHONE NO : 732 3197766
14605 28th Avenue North SE DECISION MADE: 14-AUG-23
Minneapolis MN 55447 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Aura 10 PET/CT
XEOS Medical 510(k) NO: K231420(Traditional)
ATTN: Bjorn Delbeecke PHONE NO : 0032 09 2777794
Ottergemsesteenweg-Zuid 808 Bus 35SE DECISION MADE: 10-AUG-23
Gent BE 9000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Precision GI
Limaca Medical Ltd 510(k) NO: K231422(Traditional)
ATTN: Assaf Klein PHONE NO : 972 54 2299572
3 Ha'Rimon street Mevo-Carmel ScieSE DECISION MADE: 28-AUG-23
En Ha'Emeq IL 1925000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: The Sensititre YeastOne Susceptibility System with Rezafungin in the dilution range of 0.008-8ug/mL
Thermo Fisher Scientific 510(k) NO: K231433(Traditional)
ATTN: Cynthia Knapp PHONE NO : 800 87189093 224117
1 Thermo Fisher Way SE DECISION MADE: 31-AUG-23
Oakwood Village OH 44146 510(k) STATEMENT
DEVICE: DESS Dental Smart Solutions
Terrats Medical SL 510(k) NO: K231434(Traditional)
ATTN: Roger Terrats PHONE NO : 34 935 646006
Carrer Mogoda 75-99 SE DECISION MADE: 14-AUG-23
Barbera del Valles ES 08210 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KIMTECH™ Polaris™ Xtra Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid
Kimberly-Clark Corporation 510(k) NO: K231435(Traditional)
ATTN: Kimberly Tempas PHONE NO : 920 7214084
1400 Holcomb Bridge Road SE DECISION MADE: 28-AUG-23
Roswell GA 30076 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Powder Free White, Black, and Purple Nitrile Examination Glove
S&S Glove Corporation 510(k) NO: K231439(Traditional)
ATTN: Poppy Farrah Rossa PHONE NO : 84 283 8725999
Lot 4, D6 Road, Dat Do I IndustriaSE DECISION MADE: 11-AUG-23
Ba Ria-Vung Tau VN VN790000 510(k) STATEMENT
DEVICE: Implant-One System
Implant Logistics, Inc. 510(k) NO: K231455(Traditional)
ATTN: Thomas Arendt PHONE NO : 1 608 4984855
711 Spartan Drive SE DECISION MADE: 15-AUG-23
Sparta WI 54656 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPARK Scan
SPARK Neuro Inc. 510(k) NO: K231457(Traditional)
ATTN: Marinela Gombosev PHONE NO : 949 5847331
212 West 18th Street, Unit 17A SE DECISION MADE: 18-AUG-23
New York NY 10011 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Extremity Staple
restor3d 510(k) NO: K231458(Traditional)
ATTN: Anika Moorjani PHONE NO : 501 2403476
311 West Corporation Street SE DECISION MADE: 03-AUG-23
Durham NC 27701 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Xpert Xpress CoV-2/Flu/RSV plus
Cepheid® 510(k) NO: K231481(Traditional)
ATTN: Suzette Chance PHONE NO : 262 6231775
904 Caribbean Drive SE DECISION MADE: 17-AUG-23
Sunnyvale CA 94089 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Celerity™ HP Chemical Indicator; Celerity™ HP Multivariable Chemical Indicator; VERIFY HPU Chemical Indicator; VERIFY VH2O2 Indicator Tape
STERIS 510(k) NO: K231488(Traditional)
ATTN: Anthony Piotrkowski PHONE NO : 440 3927437
5960 Heisley Rd SE DECISION MADE: 07-AUG-23
Mentor OH 44060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Celerity 20 HP Biological Indicator; VERIFY V24 Self-Contained Biological Indicator
STERIS Corporation 510(k) NO: K231490(Traditional)
ATTN: Gregory Land PHONE NO : 440 3927424
5960 Heisley Rd SE DECISION MADE: 07-AUG-23
Mentor OH 44060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TA™ Stapler and Loading Unit with DST Series™ Technology
Covidien 510(k) NO: K231491(Traditional)
ATTN: Emily Jacobs PHONE NO : 860 9336557
60 Middletown Ave. SE DECISION MADE: 16-AUG-23
North Haven CT 06473 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NITINEX Memory Compression Staple
Vilex, LLC 510(k) NO: K231493(Traditional)
ATTN: Brock Johnson PHONE NO : 801 9164157
111 Moffitt Street SE DECISION MADE: 11-AUG-23
McMinnville TN 37110 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TITAN 3-D Wedge System
Paragon 28 Inc 510(k) NO: K231496(Traditional)
ATTN: Haylie Hertz PHONE NO : 303 7200017
14445 Grasslands Drive SE DECISION MADE: 22-AUG-23
Englewood CO 80112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vis-U-All Low Temperature Sterilization Pouches
Steris Corporation 510(k) NO: K231500(Traditional)
ATTN: Jennifer Nalepka PHONE NO : 440 3927458
5960 Heisley Road SE DECISION MADE: 07-AUG-23
Mentor OH 44060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRO-LITE Sterilization Tray
STERIS Corporation 510(k) NO: K231501(Traditional)
ATTN: Jennifer Nalepka PHONE NO : 440 3927458
5960 Heisley Road SE DECISION MADE: 07-AUG-23
Mentor OH 44060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CUPTIMIZE™ Advanced
DePuy Orthopaedics, Inc 510(k) NO: K231503(Traditional)
ATTN: Sierra Robinson PHONE NO : 850 2519921
700 Orthopaedic Dr SE DECISION MADE: 22-AUG-23
Warsaw IN 46582 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Current Health System
Current Health Ltd 510(k) NO: K231506(Special)
ATTN: Giovanni Maggi PHONE NO : 44 131 2858101
The Stamp Office, Level 3, 10 WateSE DECISION MADE: 24-AUG-23
Edinburgh GB EH1 3EG 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Surgical Gown (S,M,L,XL,XXL,XXXL); Reinforced Surgical Gown (S,M,L,XL,XXL,XXXL)
Xiantao Zhibo Non-Woven Products C510(k) NO: K231510(Traditional)
ATTN: Fen Peng PHONE NO : 86 188 72609993
No. 8 Hefeng Industrial Park, PengSE DECISION MADE: 22-AUG-23
Xiantao CN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITROS Immunodiagnostic Products CEA Reagent Pack
Ortho Clinical Diagnostics 510(k) NO: K231517(Traditional)
ATTN: Rebecca Lewis PHONE NO : 440 7917 427649
Felindre Meadows Pencoed SE DECISION MADE: 23-AUG-23
Bridgend GB CF35 5PZ 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITROS Immunodiagnostic Products CA 19-9TM Reagent Pack
Ortho Clinical Diagnostics 510(k) NO: K231525(Traditional)
ATTN: Declan Hynes PHONE NO : 44 0750 5370257
Felindre Meadows Pencoed SE DECISION MADE: 09-AUG-23
Bridgend GB CF35 5PZ 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SofWave System
Sofwave Medical Ltd. 510(k) NO: K231537(Traditional)
ATTN: Ruthie Amir, MD PHONE NO : 97 254 3003164
1 Ha-Otsma St. SE DECISION MADE: 28-AUG-23
Yokneam Ilit IL 2069200 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Meical Diode Laser, Model S1Pro
Wuhan Pioon Technology Co., Ltd. 510(k) NO: K231548(Traditional)
ATTN: Feng Zhang PHONE NO : 86 180 62448535
7th Floor, A21 of Sino Pharm BuildSE DECISION MADE: 03-AUG-23
Wuhan CN 430075 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZENEX FreeMilling & CCM Cast Abutment
Izenimplant Co., Ltd. 510(k) NO: K231557(Traditional)
ATTN: Ji-Hwan Jeong PHONE NO : 82 31 6620657
1, 2Dong, 26-32, Suworam 4-Gil, SeSE DECISION MADE: 24-AUG-23
Pyeongtaek-Si KR 17703 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NIM™ 35cm long Surgeon Control Probe, 1mm Ball-Tip (NIMDTP35)
Medtronic Xomed, Inc. 510(k) NO: K231580(Traditional)
ATTN: Alexandra Oliver PHONE NO : 904 3328936
6743 Southpoint Drive North SE DECISION MADE: 30-AUG-23
Jacksonville FL 32216 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Route 92 Medical Full Length 054 Access System
Route 92 Medical, Inc. 510(k) NO: K231583(Special)
ATTN: Kirsten Valley PHONE NO : 650 2798427
155 Bovet Road, Suite 100 SE DECISION MADE: 15-AUG-23
San Mateo CA 94402 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sapphire X3 Anterior Cervical Plate System
Spinal Elements, Inc 510(k) NO: K231593(Traditional)
ATTN: Julie Lamothe PHONE NO : 760 6071816
3115 Melrose Dr., Suite 200 SE DECISION MADE: 02-AUG-23
Carlsbad CA 92010 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Stryker MP, Mandible, HMMF and MMF AXS Screws
Stryker Leibinger GmbH & Co. KG 510(k) NO: K231599(Traditional)
ATTN: Amelia Kesti PHONE NO : 269 3305919
Boetzinger Strasse 41 SE DECISION MADE: 24-AUG-23
Freiburg DE D-79111 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Protego Air Water Connector; Protego Air Water Bottle Tubing; Protego Hybrid Tubing
GA Health Company Limited 510(k) NO: K231602(Traditional)
ATTN: Cindy Ye PHONE NO : 852 28339010
Unit 18, 21/F, Metropole Square, 2SE DECISION MADE: 01-AUG-23
Hong Kong HK 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Instrument Case
Cochlear Americas 510(k) NO: K231604(Special)
ATTN: Whitney Alexander PHONE NO : 719 3378620
10350 Park Meadows Drive SE DECISION MADE: 24-AUG-23
Lone Tree CO 80124 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HOLO Portal™ Surgical Guidance System
Surgalign Spine Technologies 510(k) NO: K231611(Traditional)
ATTN: Jeremy Markovich PHONE NO : 760 5224378
520 Lake Cook Road Suite 315 SE DECISION MADE: 31-AUG-23
Deerfield IL 60015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZEUS IFA(TM) nDNA Test System, ZEUS dIFine
ZEUS Scientific 510(k) NO: K231616(Traditional)
ATTN: Mark Kopnitsky PHONE NO : 908 5263744
200 Evans Way SE DECISION MADE: 31-AUG-23
Branchburg NJ 08876 510(k) STATEMENT
DEVICE: Nuubo Smart
Smart Solutions Technologies SL 510(k) NO: K231620(Traditional)
ATTN: Borja Gonzal Vez PHONE NO :
Paseo de la Castellena 200 SE DECISION MADE: 01-AUG-23
Madrid ES 28046 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Distal Elbow Plating System
Skeletal Dynamics Inc 510(k) NO: K231623(Traditional)
ATTN: Alexandra Rodriguez Rojas PHONE NO : 305 5967585
7300 North Kendall Drive SE DECISION MADE: 28-AUG-23
Miami FL 33156 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OSPREY Closed IV Catheter System (OspreyV2)
SkyDance Vascular, Inc. 510(k) NO: K231626(Traditional)
ATTN: Scott Pease PHONE NO : 678 6898010
3058 Millcreek Road SE DECISION MADE: 31-AUG-23
Pleasant Grove UT 84062 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NorthStar OCT System
SeaSpine Inc. 510(k) NO: K231654(Traditional)
ATTN: Jesse Albright PHONE NO : 815 3422428
5770 Armada Dr. SE DECISION MADE: 03-AUG-23
Carlsbad CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Brainomix 360 e-MRI
Brainomix Limited 510(k) NO: K231656(Traditional)
ATTN: Zsolt Szrnka PHONE NO : 0044 79 49013914
First Floor Seacourt Tower West WaSE DECISION MADE: 30-AUG-23
Oxford GB OX2 0JJ 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: P200TE (A10700)
Optos Plc 510(k) NO: K231673(Traditional)
ATTN: Rachel Reay PHONE NO : 00 441 383843300
Queensferry House, Carnegie CampusSE DECISION MADE: 18-AUG-23
Dunfermline GB KY11 8GR 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CALLISTO eye
Carl Zeiss Meditec AG 510(k) NO: K231676(Traditional)
ATTN: Hans-Joachim Miesner PHONE NO : 49 3641 220362
Goeschwitzer Strasse 51-52 SE DECISION MADE: 28-AUG-23
Jena DE 07745 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AccelFix Lumbar Expandable Cage System
L&K BioMed Co., Ltd. 510(k) NO: K231680(Special)
ATTN: Katherine Kim PHONE NO : 82 10 54770325
#101, 201, 202 16-25, DongbaekjungSE DECISION MADE: 24-AUG-23
Yongin-si KR 17015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Fusion Bond 5, Fusion Bond 7, Fusion Bond DC, Renew MDP, Renew Universal
Prevest Denpro Limited 510(k) NO: K231696(Traditional)
ATTN: Atul Modi PHONE NO : 941___ 9194280
Unit II, Export Promotion IndustriSE DECISION MADE: 11-AUG-23
Bari Brahmana IN 181133 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Holmium Medical Laser
Allengers Global Healthcare Privat510(k) NO: K231718(Traditional)
ATTN: Harpreet Singh PHONE NO : 91 1762 272600
Room No.5, Khasra no. 79, BhankarpSE DECISION MADE: 18-AUG-23
Derabassi, District- Mohali IN 14510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Optional Screen Displays for HeartSee Cardiac P.E.T. Processing Software - HeartSee version 4
McGovern Medical School 510(k) NO: K231731(Traditional)
ATTN: K. Lance Gould PHONE NO : 713 5006611
6431 Fannin Street, MSB 4.256 SE DECISION MADE: 21-AUG-23
Houston TX 77030 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MA012 Aluminum wheelchair, MS019 steel wheelchair
Sichuan AST Medical Equipment Co.,510(k) NO: K231750(Traditional)
ATTN: Mae Tse PHONE NO : 86 830 8130333
No.58 JinPeng Road, Area C, West ISE DECISION MADE: 15-AUG-23
Luzhou City CN 646100 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Stable-C Interbody System
Nexus Spine, LLC 510(k) NO: K231763(Traditional)
ATTN: Jared Crocker PHONE NO : 801 7028592
2825 East Cottonwood Parkway SuiteSE DECISION MADE: 21-AUG-23
Salt Lake City UT 84121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Electrosurgical Generator ESG-410 and Accessories (WA91327U, WA91327W), Accessories: Foot switches (WA91311W, WA91321W)
Olympus Winter & Ibe GmbH 510(k) NO: K231777(Traditional)
ATTN: Ian Pericevic PHONE NO : 49 40 669660
Kuehnstrasse 61 SE DECISION MADE: 18-AUG-23
Hamburg DE 22045 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: primaLOK™ SP Interspinous Fusion System
Wenzel Spine, Inc. 510(k) NO: K231807(Traditional)
ATTN: William Wilson PHONE NO : 512 4690600
1130 Rutherford Lane, Suite 200 SE DECISION MADE: 15-AUG-23
Austin TX 78753 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Zavation Connector System
Zavation Medical Products, LLC 510(k) NO: K231811(Traditional)
ATTN: Noah Slack PHONE NO : 601 9191119
3670 Flowood Dr. SE DECISION MADE: 22-AUG-23
Flowood MS 39232 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NOxBOXi Nitric Oxide Delivery System
Linde Gas & Equipment Inc. 510(k) NO: K231823(Special)
ATTN: Dave Loflin PHONE NO : 412 8743315
208 W Main St. SE DECISION MADE: 11-AUG-23
Livingston TN 38570 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Xenix Medical Sacroiliac Fixation System
HT Medical d.b.a. Xenix Medical 510(k) NO: K231829(Traditional)
ATTN: Teresa Cherry PHONE NO : 888 5948633
111 W Jefferson St., Suite 100 SE DECISION MADE: 15-AUG-23
Orlando FL 32801 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TiLink-L Joint Fusion System
SurGenTec 510(k) NO: K231831(Special)
ATTN: Andrew Shoup PHONE NO : 561 9907882
911 Clint Moore Rd SE DECISION MADE: 03-AUG-23
Boca Raton FL 33487 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RxSight® Insertion Device (63002)
RxSight, Inc. 510(k) NO: K231838(Traditional)
ATTN: Maureen OConnell PHONE NO : 978 2071245___
100 Columbia SE DECISION MADE: 15-AUG-23
Aliso Viejo CA 92656 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Arthrex TightRope II
Arthrex Inc. 510(k) NO: K231857(Traditional)
ATTN: Kristi Frisch PHONE NO : 1 239 5984302 73849
1370 Creekside Boulevard SE DECISION MADE: 08-AUG-23
Naples FL 34108-1945 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Grappler Suture Anchor System
Paragon 28, Inc. 510(k) NO: K231867(Traditional)
ATTN: Edward Wells-Spicer PHONE NO : 585 4552810
14445 Grasslands Dr SE DECISION MADE: 21-AUG-23
Englewood CO 80112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Polaris Bipolar Electrosurgical Generator (29-1000); Polaris Irrigation Module (29-1600); Polaris Light Source Module (29-1900); Dual Footswitch (29-1020)
Kirwan Surgical Products LLC 510(k) NO: K231872(Traditional)
ATTN: Matthew Prario PHONE NO : 781 8349500
180 Enterprise Drive SE DECISION MADE: 25-AUG-23
Marshfield MA 02050 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Medline UNITE® REFLEX® Nitinol Staple System
Medline Industries, LP 510(k) NO: K231885(Traditional)
ATTN: Jennifer Mason PHONE NO : 847 6433652
Three Lakes Drive SE DECISION MADE: 09-AUG-23
Northfield IL 60093 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Montage-QS Settable, Resorbable Bone Putty
Orthocon, Inc. 510(k) NO: K231903(Traditional)
ATTN: Aniq Darr PHONE NO : 855 4759175
700 Fairfield Avenue- Suite 1 SE DECISION MADE: 25-AUG-23
Stamford CT 06902 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Electro-Spec Steri-Caps
Electro-Spec, Inc 510(k) NO: K231905(Traditional)
ATTN: Jeff Smith PHONE NO : 1 317 7390924
1800 Commerce Parkway SE DECISION MADE: 14-AUG-23
Franklin IN 46131 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Mineral Collagen Composite Bioactive Extra Moldable
Collagen Matrix, Inc. 510(k) NO: K231942(Special)
ATTN: Victoria Augustine PHONE NO : 646 2229564
15 Thornton Rd. SE DECISION MADE: 02-AUG-23
Oakland NJ 07436 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CATAMARAN SI Joint Fusion System
Tenon Medical, Inc. 510(k) NO: K231944(Traditional)
ATTN: Susan Noreiga PHONE NO : 650 7931966
104 Cooper Court SE DECISION MADE: 24-AUG-23
Los Gatos CA 95032 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Aristotle 18 Guidewire; Aristotle 24 Guidewire
Scientia Vascular, Inc. 510(k) NO: K231954(Special)
ATTN: Bailey Johannsen PHONE NO : 888 3859016
2460 S 3270 W SE DECISION MADE: 01-AUG-23
West Valley City UT 84119 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EXPD 4357; EXPD 4357P
DRTECH Corporation 510(k) NO: K231959(Special)
ATTN: Lee Youna PHONE NO : 82 31 7797710
Suite No.1, 2 Floor/Suite No. 2, 3SE DECISION MADE: 01-AUG-23
Seongnam-si KR 13216 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NIBPCuff
Shenzhen SINO-K Medical Technology510(k) NO: K231961(Traditional)
ATTN: Lao Chengxin PHONE NO : 86 137 15333326
Room401,Bldg2,Veteran Ind.city,GonSE DECISION MADE: 30-AUG-23
Shenzhen CN 518115 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REAL INTELLIGENCE™ CORI™
Blue Belt Technologies, Inc. 510(k) NO: K231963(Special)
ATTN: Corrine Herlinger PHONE NO : 412 5526428
2875 Railroad Street SE DECISION MADE: 01-AUG-23
Pittsburgh PA 15222 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BioSieve™ Marijuana Test Panel 50; BioSieve™ Marijuana Test Strip 50; BioSieve™ Dx Marijuana Test Strip 20; BioSieve™ Dx Marijuana Test Strip 50; BioSieve™ Dx Marijuana Test Panel 20; BioSieve™ Dx Marijuana Test Panel 50
VivaChek Biotech (Hangzhou) Co., L510(k) NO: K231978(Traditional)
ATTN: Jessica Chen PHONE NO : 86 182 57349413
Floor 2, Block 2, 146 East ChaofenSE DECISION MADE: 31-AUG-23
Hangzhou CN 311100 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sensititre 20-24-hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Dalbavancin in the dilution range of 0.0005-2µg/ml
Thermo Fisher Scientific 510(k) NO: K231988(Traditional)
ATTN: Joel Mathew PHONE NO : 978 9074417
One Thermo Fisher Way SE DECISION MADE: 30-AUG-23
Oakwood Village OH 44146 510(k) STATEMENT
DEVICE: Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Sulbactam-durlobactam in the dilution range of 0.015/4-32/4 ug/mL
Thermo Fisher Scientific 510(k) NO: K231994(Traditional)
ATTN: Cynthia Knapp PHONE NO : 1 216 2122844
One Thermo Fisher Way SE DECISION MADE: 25-AUG-23
Oakwood Village OH 44146 510(k) STATEMENT
DEVICE: HEALICOIL PK Suture Anchor with Needles, ULTRATAPE (Blue); HEALICOIL PK Suture Anchor with Needles, ULTRATAPE (Blue Cobraid)
Smith & Nephew, Inc. 510(k) NO: K232005(Special)
ATTN: Camille Fleischer PHONE NO : 978 7491057
150 Minuteman Road SE DECISION MADE: 04-AUG-23
Andover MA 01810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LEGACY® IPC
IG Technology Ltd 510(k) NO: K232006(Third Party - Traditional)
ATTN: Ivan Green PHONE NO : 440 7770 386797
Wylcut House, 316 Petre St SE DECISION MADE: 04-AUG-23
Sheffield GB S33 0AW 510(k) STATEMENT
THIRD PARTY REVIEW
DEVICE: Disposable Medical Examination Nitrile Gloves
Raxwell Industrial LLC 510(k) NO: K232008(Third Party - Traditional)
ATTN: Xianda Yao PHONE NO : 1 765 4300178___
20323 Bristol Bluff Ln SE DECISION MADE: 08-AUG-23
Richmond TX 77407 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: iTEMPSHIELD
AION Biosystems Inc. 510(k) NO: K232010(Third Party - Traditional)
ATTN: Joseph Azary PHONE NO : 203 2426670
12 Plymouth Road SE DECISION MADE: 04-AUG-23
Darien CT 06820 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: ATMOS Scope (507.7000.0); ATMOS Scope Pro (507.7050.0); ATMOS Scope iPrime (507.7060.0)
ATMOS MedizinTechnik GmbH & Co. KG510(k) NO: K232015(Traditional)
ATTN: Reinhold Storch PHONE NO : 49 7653 689647
Ludwig-Kegel-Str. 16 SE DECISION MADE: 03-AUG-23
Lenzkirch DE 79853 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ingenia Elition R5.7.1 SP4 MR Systems
Philips Medical Systems Nederland 510(k) NO: K232030(Special)
ATTN: Ioana Ulea PHONE NO : 31 618 345875
Veenpluis 6 SE DECISION MADE: 02-AUG-23
Best NL 5684PC 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
Grand Work Plastic Products Co., L510(k) NO: K232039(Special)
ATTN: Wu Yuli PHONE NO : 86 311 66179668
Donggao Industrial Zone SE DECISION MADE: 09-AUG-23
Zanhuang CN 050000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ceribell Instant EEG Headband
Ceribell, Inc. 510(k) NO: K232052(Special)
ATTN: Raymond Woo PHONE NO : 650 5564349
360 North Pastoria Avenue SE DECISION MADE: 08-AUG-23
Sunnyvale CA 94085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: YosemiteView 4343W/YosemiteView 3643W
CareRay Digital Medical Technology510(k) NO: K232058(Special)
ATTN: Xu Wei PHONE NO : 86 512 86860288
A2-201/B3-501, Biobay,218 Xinghu SSE DECISION MADE: 03-AUG-23
Suzhou CN 215123 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Efai Pacs Picture Archiving and Communication System Pro
Ever Fortune.AI Co., Ltd. 510(k) NO: K232100(Special)
ATTN: Joseph Chang PHONE NO : 866 4 23226363
8 F., No. 573, Sec. 2, Taiwan BlvdSE DECISION MADE: 08-AUG-23
Taichung City TW 403020 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CoreLink Navigation Instruments
CoreLink, LLC 510(k) NO: K232116(Special)
ATTN: Steven Mounts PHONE NO : 888 3497808___
2072 Fenton Logistics Park SE DECISION MADE: 16-AUG-23
St. Louis MO 63026 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EEA™Circular Stapler with Tri-Staple™ Technology and OrVil™ Transoral Circular Stapler Anvil
Covidien 510(k) NO: K232126(Special)
ATTN: Helen Chen PHONE NO : 86 21 33230135
Room 501, 502, 601, 602, No. 3 BuiSE DECISION MADE: 16-AUG-23
Min Hang District, Shanghai CN 20510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 21HQ513D, 32HL512D, 31HN713D, 32HQ713D
LG Electronics Inc. 510(k) NO: K232127(Special)
ATTN: Daseul An PHONE NO : 82 31 80665641
168, Suchul-daero SE DECISION MADE: 15-AUG-23
Gumi-si KR 39368 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LifeSPARC System
CardiacAssist, Inc. 510(k) NO: K232132(Special)
ATTN: Arielle Drummond PHONE NO : 412 8899021
620 Alpha Drive SE DECISION MADE: 03-AUG-23
Pittsburgh PA 15238 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CD Horizon ModuLeX FNS Screw Set (Fenestrated Screw); CD Horizon ModuLeX Spinal System (Modular Extended Tab Head)
Medtronic Sofamor Danek USA, Inc. 510(k) NO: K232141(Special)
ATTN: Kelly McDonnell PHONE NO : 1 651 2699806
1800 Pyramid Place SE DECISION MADE: 16-AUG-23
Memphis TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sterile Products of the APTUS System
Medartis AG 510(k) NO: K232144(Special)
ATTN: Claudia De Santis PHONE NO : 41 61 6333434
Hochbergerstrasse 60E SE DECISION MADE: 18-AUG-23
Basel CH 4057 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZSFab Cervical Interbody System
ZSFab Inc. 510(k) NO: K232150(Special)
ATTN: Xuewei Ma PHONE NO : 617 4688665
96 Clematis Ave, Suite 2F SE DECISION MADE: 18-AUG-23
Walthan MA 02453 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Avéli
Revelle Aesthetics, Inc. 510(k) NO: K232153(Special)
ATTN: Melissa Viotti PHONE NO : 650 3365985
2570 W El Camino Real, Suite 310 SE DECISION MADE: 18-AUG-23
Mountain View CA 94040 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Connected OR Hub with Device and Voice Control, SDC4K Information Management System with Device and Voice Control
Stryker Corporation 510(k) NO: K232157(Special)
ATTN: Janki Bhatt PHONE NO : 669 2153045
5900 Optical Ct SE DECISION MADE: 18-AUG-23
San Jose CA 95138 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Autotome Pro RX 39 Sphincterotome; Autotome Pro RX 44 Sphincterotome; Jagtome Pro RX 44 Sphincterotome; Jagtome Pro RX 39 Sphincterotome; Dreamtome Pro RX 44 Sphincterotome; Hydratome Pro RX 44 Sphincterotome; Jagtome Revolution Pro RX 39 Sphincterotome
Boston Scientific Corporation 510(k) NO: K232162(Special)
ATTN: Stephanie Gorman PHONE NO : 508 3820441
100 Boston Scientific Way SE DECISION MADE: 14-AUG-23
Marlborough MA 01752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SM-IV
Sedecal SA 510(k) NO: K232185(Special)
ATTN: Mª Luisa Gómez de Agüero PHONE NO : 34 91 6280544
C/ Pelaya, 9 - 13 Pol. Ind. Río DeSE DECISION MADE: 21-AUG-23
Algete ES 28110 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 6F Sherpa NX Balanced Guide Catheter, 7F Sherpa NX Balanced Guide Catheter
Medtronic Vascular 510(k) NO: K232190(Special)
ATTN: Colleen Gentile PHONE NO : 1 508 8436178
37A Cherry Hill Drive SE DECISION MADE: 22-AUG-23
Danvers MA 01923 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OMNI Surgical System
Sight Sciences Inc., 510(k) NO: K232214(Special)
ATTN: Ranjani Madhavan PHONE NO : 737 2470998
4040 Campbell Ave, Suite 100 SE DECISION MADE: 25-AUG-23
Menlo Park CA 94025 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Quantra Hemostasis Analyzer
HemoSonics, LLC 510(k) NO: K232215(Special)
ATTN: Debbie Winegar PHONE NO : 919 2446990
4020 Stirrup Creek Drive, Suite 10SE DECISION MADE: 24-AUG-23
Durham NC 27703 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Zenius™ Spinal System
Medyssey USA, Inc. 510(k) NO: K232218(Special)
ATTN: Youngsu Jang PHONE NO : 847 4270200
43176 Business Park Dr Ste 107 SE DECISION MADE: 24-AUG-23
Temecula CA 92590 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARROW Off-Centred Humeral Insert
FH Industrie 510(k) NO: K232226(Special)
ATTN: Naoual Rahimi PHONE NO : 33 02 56102046
6 rue Nobel, Zi De Kernevez SE DECISION MADE: 29-AUG-23
Quimper FR 29000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EVO 700 series high speed handpiece
Ttbio Corp. 510(k) NO: K232243(Special)
ATTN: Sheng-Chieh Su PHONE NO : 886 4 23595958
2F., No.7, 6th Road Industry Park SE DECISION MADE: 23-AUG-23
Taichung CN 40755 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RAYSCAN a-Expert3D
Ray Co., Ltd. 510(k) NO: K232287(Special)
ATTN: Sooji Huh PHONE NO : 82 605 1000
1F~3F, 4F(Part), 5F, 265, Daeji-RoSE DECISION MADE: 31-AUG-23
Yongin-si KR 16882 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Essenz HLM, Essenz ILBM
LivaNova Deutschland GmbH 510(k) NO: K232291(Special)
ATTN: Florian Goetz PHONE NO : 49 89 32301236
Lindberghstr. 25 SE DECISION MADE: 24-AUG-23
Munich DE 80939 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LAA Exclusion System
Syntheon, LLC 510(k) NO: K232295(Special)
ATTN: Toygar Unal PHONE NO : 973 9978532
13755 SW 119 Avenue SE DECISION MADE: 30-AUG-23
Miami FL 33186 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation System
L&K Biomed Co., Ltd. 510(k) NO: K232311(Special)
ATTN: Katherine Kim PHONE NO : 82 10 54770325
#101, 201, 202 16-25, DongbaekjungSE DECISION MADE: 14-AUG-23
Yongin-si KR 17015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIGACLIP Endoscopic Rotating Multiple Clip Applier 12mm L (ER420); LIGACLIP Endoscopic Rotating Multiple Clip Applier 10mm M/L (ER320)
Ethicon Endo Surgery, LLC. 510(k) NO: K232313(Special)
ATTN: Lakrisha Tinner PHONE NO : 517 3377475
475 Calle C SE DECISION MADE: 29-AUG-23
Guaynabo PR 00969 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: StealthFix Intraosseous Fixation System
Medartis Inc. 510(k) NO: K232324(Special)
ATTN: Chelsea Kozior PHONE NO : 610 7318650
1195 Polk Drive SE DECISION MADE: 30-AUG-23
Warsaw IN 46582 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AC3™ Series IABP
Arrow International, LLC 510(k) NO: K232343(Special)
ATTN: Sheila Payzant PHONE NO : 763 6564290
3015 Carrington Mill Blvd SE DECISION MADE: 30-AUG-23
Morrisville NC 27560 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Powder Free Nitrile Examination Gloves (Black)
Shanxi Hongjin Plastic Technology 510(k) NO: K232353(Special)
ATTN: Wu Zhigang PHONE NO : 86 311 66179668
Coal Bed Gas Industrial Zone, Qu'eSE DECISION MADE: 31-AUG-23
Linfen CN 042300 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Treace Medical Concepts (TMC) Compression Implant System
Treace Medical Concepts 510(k) NO: K232387(Special)
ATTN: Brittany Grochala PHONE NO : 515 8650494
100 Palmetto Park Place SE DECISION MADE: 28-AUG-23
Ponte Vedra FL 32081 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UltraSeal XT plus - Bioprotection by Nobio, UltraSeal XT hydro - Bioprotection by Nobio
Ultradent Product, Inc. 510(k) NO: K232498(Third Party - Traditional)
ATTN: Ruth Gardner PHONE NO : 801 5534431
505 West Ultradent Drive (10200 SoSE DECISION MADE: 18-AUG-23
South Jordan UT 84095 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
TOTAL 510(k)s THIS PERIOD 310
TOTAL WITH SUMMARIES 289
TOTAL WITH STATEMENTS 21
