510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD September 2023
DEVICE: Ki Mobility Focus CR, Ki Mobility Focus CRe, Ki Mobility Focus CR TTL
Ki Mobility LLC 510(k) NO: K200583(Traditional)
ATTN: Mark Murphy PHONE NO : 715 2540992
5201 Woodward Drive SE DECISION MADE: 05-SEP-23
Stevens Point WI 54481 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ki Power Tilt System
Ki Mobility LLC 510(k) NO: K201869(Traditional)
ATTN: Mark Murphy PHONE NO : 715 2540992
5201 Woodward Drive SE DECISION MADE: 05-SEP-23
Stevens Point WI 54481 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DYNEX SmartPLEX MMRV IgG Assay Kit
Dynex Technologies Inc. 510(k) NO: K212769(Traditional)
ATTN: Jeff Fisher PHONE NO : 703 8031266
14340 Sullyfield Circle SE DECISION MADE: 29-SEP-23
Chantilly VA 20151 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Brain Anesthesia Response Monitor (Bar Monitor)
Cortical Dynamics Ltd 510(k) NO: K213273(Traditional)
ATTN: Louis Delacretaz PHONE NO : 61 3 87411130
14 View Street SE DECISION MADE: 01-SEP-23
North Perth AU 6006 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Aptiva CTD Essential Reagent
Inova Diagnostics, Inc. 510(k) NO: K213403(Traditional)
ATTN: Andrea Seaman PHONE NO : 858 586990 77395
9900 Old Grove Road SE DECISION MADE: 29-SEP-23
San Diego CA 92131 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Hemostatic Dressing
Jiangsu NewValue Medical Products 510(k) NO: K213413(Traditional)
ATTN: Lu Wang PHONE NO : 86 015 951155167
Building G35.the east of KouTai RoSE DECISION MADE: 01-SEP-23
TaiZhou CN 225300 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMMULITE/IMMULITE 1000 OM-MA, IMMULITE 2000 OM-MA
Siemens Healthcare Diagnostics Pro510(k) NO: K213510(Traditional)
ATTN: Stefani Vinkemeier PHONE NO : 302 4899232
Glyn Rhonwy, Llanberis Caernarfon SE DECISION MADE: 08-SEP-23
Llanberis GB LL55 4EL 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Access Thyroglobulin Antibody II
Beckman Coulter, Inc. 510(k) NO: K213517(Traditional)
ATTN: Abhi Kannan PHONE NO : 1 905 5560843
1000 Lake Hazeltine Dr SE DECISION MADE: 26-SEP-23
Chaska MN 55318 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Endure ETCO2/02 Nasal Cannula
Endure Industries Inc 510(k) NO: K213767(Traditional)
ATTN: Manoj Kumar PHONE NO : 607 5914274
45 N Fulton St SE DECISION MADE: 12-SEP-23
Homer NY 13077 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARCHITECT HSV-1 IgG, ARCHITECT HSV-1 IgG Calibrator, ARCHITECT HSV-1 IgG Controls
Biokit, S.A. 510(k) NO: K213987(Traditional)
ATTN: Angels Roma PHONE NO : 34 938 609000
Av. Can Montcau, 7 SE DECISION MADE: 20-SEP-23
Llica d’Amunt ES 08186 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Afinion™ HbA1c, Afinion™ 2 and Alere Afinion™ AS100 Analyzer
Abbott Diagnostics Technologies AS510(k) NO: K214117(Dual Track)
ATTN: Danial Kirmani PHONE NO : 1 224 4193742
Kjelsasveien 161 SE DECISION MADE: 27-SEP-23
Oslo NO NO-0884 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: High-Speed Air Turbine Handpieces/Straight Handpieces/Geared Angle Handpieces/Air Motors
Foshan COXO Medical Instrument Co.510(k) NO: K220179(Traditional)
ATTN: Zheng Yongjian PHONE NO : 86 137 02544788
BLDG 4,District A Guangdong New LiSE DECISION MADE: 22-SEP-23
Foshan CN 528226 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ADVIA Centaur® NT-proBNPII (PBNPII)
Siemens Healthcare Diagnostics, In510(k) NO: K220265(Traditional)
ATTN: Asha Gartland PHONE NO : 845 3278296
511 Benedict Ave SE DECISION MADE: 24-SEP-23
Tarrytown NY 10591 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EasyStat 300
Medica corporation 510(k) NO: K220396(Traditional)
ATTN: Photios Makris PHONE NO : 781 5417443
5 Oak Park Drive SE DECISION MADE: 26-SEP-23
Bedford MA 01730 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UltraFlo-R Push Button Blood Collection Set
Innovative Medical Technologies, I510(k) NO: K220458(Traditional)
ATTN: Brad Brown PHONE NO : 913 5150917
14315 C Circle SE DECISION MADE: 29-SEP-23
Omaha NE 68144 510(k) STATEMENT
DEVICE: Avologi Gel Primer (Model: Av25)
Premier North America Inc. 510(k) NO: K220735(Traditional)
ATTN: Ellis Tamari PHONE NO : 404 492813311_
3301 SW 42nd Street SE DECISION MADE: 15-SEP-23
Fort Lauderdale FL 33312-6828 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Access Thyroglobulin
Beckman Coulter, Inc 510(k) NO: K220972(Traditional)
ATTN: Abhi Kannan PHONE NO : 1 905 5560843
1000 Lake Hazeltine Dr SE DECISION MADE: 15-SEP-23
Chaska MN 55318 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Self-Fitting hearing aids
Huizhou Jinghao Medical Technology510(k) NO: K221052(Traditional)
ATTN: Yuanxia Mao PHONE NO : 086 752 2266961
Floor 6, Huicheng Industry BuildinSE DECISION MADE: 25-SEP-23
Huizhou CN 516006 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITROS Immunodiagnostic Products Intact PTH II Reagent Pack
Ortho Clinical Diagnostics 510(k) NO: K221197(Traditional)
ATTN: Declan Hynes PHONE NO : 44 0750 5370257
Felindre Meadows Pencoed SE DECISION MADE: 05-SEP-23
Bridgend GB CF24 1QR 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: StarFormer, TightWave
Fotona d.o.o. 510(k) NO: K221274(Traditional)
ATTN: Tina Bartolic PHONE NO : 386 1 5009100
Stegne 7 SE DECISION MADE: 29-SEP-23
Ljubljana SI 1000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AI100 with Shonit
SigTuple Technologies Pvt. Ltd. 510(k) NO: K221309(Traditional)
ATTN: Tathagato Rai Dastidar PHONE NO : 91 934 1232063
First Floor, L-162, 14th Cross RoaSE DECISION MADE: 19-SEP-23
Bangalore IN 560102 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein-I IgM
Instrumentation Laboratory Co. 510(k) NO: K221359(Traditional)
ATTN: Nikita Malladi PHONE NO : 781 3531486
180 Hartwell Road SE DECISION MADE: 29-SEP-23
Bedford MA 01730 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AnemoCheck Home
Sanguina, Inc. 510(k) NO: K221508(Traditional)
ATTN: Cathryn Cambria PHONE NO : 404 5435909
147 Technology Parkway Ste 100 SE DECISION MADE: 29-SEP-23
Peachtree Corners GA 30092 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Antibacterial bandage
Allmed Medical Products Co., Ltd. 510(k) NO: K221570(Traditional)
ATTN: Vince Tian PHONE NO : 86 717 4211111
No. 99, Jin Shan Road, Majiadian TSE DECISION MADE: 29-SEP-23
Zhijiang CN 430000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MS-39
C.S.O. S.r.l. 510(k) NO: K221601(Traditional)
ATTN: Gilda Mura PHONE NO : 39 055 722191
Via degli Stagnacci, 12/E SE DECISION MADE: 01-SEP-23
Scandicci IT 50018 510(k) STATEMENT
DEVICE: AlloMap Heart Molecular Expression Testing
CareDx, Inc. 510(k) NO: K221640(Traditional)
ATTN: Camilla Lu PHONE NO : 415 2872300
3260 Bayshore Boulevard SE DECISION MADE: 13-SEP-23
Brisbane CA 94005 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Radio Frequency Plasma Surgical Systems; Radio Frequency Plasma Surgical Electrodes
Jiangsu Bonss Medical Technology C510(k) NO: K221743(Traditional)
ATTN: Feir Zeng PHONE NO : 86 0523 86813258
Building #7, No. 898 China MedicalSE DECISION MADE: 07-SEP-23
Taizhou CN 225316 510(k) STATEMENT
DEVICE: ALFIS Vitamin D, ALFIS-3 Analyzer
Immunostics Inc. 510(k) NO: K221817(Traditional)
ATTN: Young Mi Kim PHONE NO : 732 9170770
38 Industrial Way East, Suite 1 SE DECISION MADE: 22-SEP-23
Eatontown NJ 07724 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe, PLPT LDV(Low Dead Volume) LL(Luer-Lock) Sterile Syringe
Poonglim Pharmatech Inc. 510(k) NO: K221860(Traditional)
ATTN: Hee Min Cho PHONE NO : 82 63 4518141
21, Jayumuyeok 1-Gil SE DECISION MADE: 15-SEP-23
Gunsan KR 54001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BCR-ABL1 (p210) % IS Kit (Digital PCR Method)
Suzhou Sniper Medical Technologies510(k) NO: K221869(Traditional)
ATTN: Peng Zhang PHONE NO : 86 0512 62809514
Unit 301, Building A6, Suzhou BioBSE DECISION MADE: 05-SEP-23
Suzhou CN 215123 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Elecsys Tg II
Roche Diagnostics 510(k) NO: K221890(Traditional)
ATTN: Edie Eads PHONE NO : 317 7348046
9115 Hague Road SE DECISION MADE: 30-SEP-23
Indianapolis IN 42650 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Stat Profile Prime Plus Analyzer System
Nova Biomedical Corporation 510(k) NO: K221900(Traditional)
ATTN: Sharvari Nayak PHONE NO : 781 6473700 1626
200 Prospect St. SE DECISION MADE: 29-SEP-23
Waltham MA 02454 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: B·R·A·H·M·S CgA II KRYPTOR, B·R·A·H·M·S CgA II KRYPTOR CAL, B·R·A·H·M·S CgA II KRYPTOR QC
B.R.A.H.M.S GmbH part of Thermo Fi510(k) NO: K222251(Traditional)
ATTN: Anne Kummerow PHONE NO : 49 3302 8832218
Neuendorfstrasse 25 SE DECISION MADE: 18-SEP-23
Hennigsdorf DE 16761 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Elecsys Anti-Tg
Roche Diagnostics 510(k) NO: K222610(Traditional)
ATTN: Phil Williams PHONE NO : 1 317 2095478
9115 Hague Road SE DECISION MADE: 15-SEP-23
Indianapolis IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Xpert® Xpress GBS, GeneXpert® Dx System, GeneXpert® Infinity Systems
Cepheid 510(k) NO: K222638(Traditional)
ATTN: Suzette Chance PHONE NO : 262___ 6231775
904 Caribbean Drive SE DECISION MADE: 27-SEP-23
Sunnyvale CA 94089 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Osstem Implant System
Osstem Implant CO., LTD. 510(k) NO: K222778(Traditional)
ATTN: Seungju Kang PHONE NO : 82 70 48710203
66-16, Bansong-ro 513beon-gil, HaeSE DECISION MADE: 23-SEP-23
Busan KR 48002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AeroDVx Arm System
Sun Scientific Inc 510(k) NO: K222823(Traditional)
ATTN: Allan Alward PHONE NO : 914 4795108
145 Palisade Street Ste: LL11 SE DECISION MADE: 07-SEP-23
Dobbs Ferry NY 10522 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CRYOcheck Factor VIII Deficient Plasma with VWF
Precision BioLogic Inc. 510(k) NO: K222831(Traditional)
ATTN: Karen Black PHONE NO : 902 4686422 226
140 Eileen Stubbs Avenue SE DECISION MADE: 13-SEP-23
Dartmouth CA B3B 0A9 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Minuteful-kidney test
Healthy.io Ltd. 510(k) NO: K222921(Traditional)
ATTN: Ron Zohar PHONE NO : 972 54 4454514
8 Yitzhak Sadeh Street SE DECISION MADE: 08-SEP-23
Tel Aviv IL 6777508 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ablation-fit
R.A.W. Srl 510(k) NO: K222938(Traditional)
ATTN: Chiara Ferrari PHONE NO : 39 3400 74759
Via Soperga 13 SE DECISION MADE: 12-SEP-23
Milan IT 20127 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Q Distal Access Catheter
MIVI Neuroscience, Inc 510(k) NO: K222948(Traditional)
ATTN: Srija Reddy Bandari PHONE NO : 612 4472897
6545 City West Parkway SE DECISION MADE: 19-SEP-23
Eden Prairie MN 55344 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: neoWave LS Lumbar Straight, neoWave C Cervical, and Ti3D Cervical
HT Medical d.b.a. Xenix Medical 510(k) NO: K222988(Traditional)
ATTN: Ryan Phillips PHONE NO : 888 5948633 701
111 W. Jefferson Street, Suite 100SE DECISION MADE: 01-SEP-23
Orlando FL 32081 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Miris Human Milk Analyzer (HMA)
Miris AB 510(k) NO: K223085(Traditional)
ATTN: Elin Hallen PHONE NO : 46 18 146907
Danmarksgatan 26 SE DECISION MADE: 29-SEP-23
Uppsala SE 75323 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cholestech LDX ™ System
Alere San Diego, Inc. 510(k) NO: K223179(Dual Track)
ATTN: Nathifa Bradshaw PHONE NO : 561 4282203
9975 Summers Ridge Rd SE DECISION MADE: 20-SEP-23
San Diego CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Powder-Free Nitrile Examination Gloves
Global Protection Corp. 510(k) NO: K223214(Abbreviated)
ATTN: Christina Cataldo PHONE NO : 617 9462800
12 Channel Street SE DECISION MADE: 21-SEP-23
Boston MA 02210 510(k) STATEMENT
DEVICE: EGIS Biliary Single Bare Stent
S&G Biotech Inc. 510(k) NO: K223354(Traditional)
ATTN: Sung-Kwon Kang PHONE NO : 82 31 7486625
82, Bugok-ro, Pogok-eup, Cheoin-guSE DECISION MADE: 21-SEP-23
Yongin-si KR 17023 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MedCAD AccuPlan Orthopedics System
MedCAD 510(k) NO: K223421(Traditional)
ATTN: Brian Buss PHONE NO : 214___ 4538864
501 S 2nd Ave, Suite A-1000 SE DECISION MADE: 20-SEP-23
Dallas TX 75226 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Inclusive® Titanium Abutments compatible with: Straumann® Bone Level SC, BioHorizons® Tapered Internal, MIS® C1 Implant Systems
Prismatik Dentalcraft, Inc. 510(k) NO: K223496(Traditional)
ATTN: So Hyun Park PHONE NO : 949 8635479
2144 Michelson Drive SE DECISION MADE: 26-SEP-23
Irvine CA 92612 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Phoenix ICON, Phoenix ICON GO
NeoLight, LLC 510(k) NO: K223575(Traditional)
ATTN: Amy Oakes PHONE NO : 480 3042165
6630 Owens Drive SE DECISION MADE: 06-SEP-23
Pleasanton CA 94588 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DeepXray
Alpha Intelligence Manifolds, Inc.510(k) NO: K223621(Traditional)
ATTN: Qingzong Tseng PHONE NO : 886 2 22406570
2F, No. 170, Zhonghe Rd., Zhonghe SE DECISION MADE: 08-SEP-23
New Taipei City TW 235068 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FaceHeart Vitals Software Development Kit (FH vitals SDK)
FaceHeart Corp. 510(k) NO: K223622(Traditional)
ATTN: Morris Chung PHONE NO : 886 3 6591088
PO Box 309, Ugland House SE DECISION MADE: 01-SEP-23
Grand Cayman KY KY1-1104 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Jazz
AI Medical AG 510(k) NO: K223659(Traditional)
ATTN: Christian Federau PHONE NO : 41 78 8402880
Goldhaldenstr 22a SE DECISION MADE: 22-SEP-23
Zollikon CH 8702 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: eZSURE™ Empty Fluid Container (models 426030, 426040, 426110)
Epic Medical Pte Ltd 510(k) NO: K223674(Traditional)
ATTN: Freddie Lee PHONE NO : 65 9 6352618
105 Cecil, 20-01 The Octagon SE DECISION MADE: 01-SEP-23
Singapore SG 069534 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: F&P 820 Humidification System
Fisher & Paykel Healthcare Ltd 510(k) NO: K223684(Traditional)
ATTN: Reena Daken PHONE NO : 64 5740100
15 Maurice Paykel Place, East TamaSE DECISION MADE: 05-SEP-23
Auckland NZ 2013 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: i-STAT G cartridge with the i-STAT 1 System
Abbott Point of Care Inc. 510(k) NO: K223755(Traditional)
ATTN: Mojgan Soleimani PHONE NO : 613 2950932
400 College Road Test SE DECISION MADE: 11-SEP-23
Princeton NJ 08540 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: The MedSource TrueSafe Blood Control I.V. Safety Catheter, and the MedSource ClearSafe Blood Control I.V. Safety Catheter
MedSource International LLC 510(k) NO: K223788(Traditional)
ATTN: Amanda Salentine PHONE NO : 952 2418318___
8600 Shelby Court, Suite 100 SE DECISION MADE: 15-SEP-23
Chanhassen MN 55317 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Lung-CAD
Imagen Technologies, Inc 510(k) NO: K223811(Traditional)
ATTN: Rebecca Jones, PhD PHONE NO : 322 255 4192
594 Broadway, Suite 701 SE DECISION MADE: 13-SEP-23
New York NY 10012 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sensis Vibe (VD15)
Siemens Medical Solutions USA Inc.510(k) NO: K223812(Traditional)
ATTN: Patricia D Jones PHONE NO : 678 5758832
40 Liberty Boulevard SE DECISION MADE: 15-SEP-23
Malvern PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FUJIFILM Endoscope Model EC-760S-A/L, Endoscopy Support Program EW10-VM01
FUJIFILM Corporation 510(k) NO: K223827(Traditional)
ATTN: Randy Vader PHONE NO : 360 3566821
798 Miyanodai Kaisei-Machi SE DECISION MADE: 08-SEP-23
Ashigarakami-Gun JP 258-8538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapter Trays
Exactech, Inc 510(k) NO: K223833(Traditional)
ATTN: Liz Howell PHONE NO : 352___ 3162640
2320 NW 66th CT SE DECISION MADE: 14-SEP-23
Gainesville FL 32653 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MA-40, MA-112
Medify Air LLC 510(k) NO: K223835(Traditional)
ATTN: Pragati Anand PHONE NO : 512 5541781
150 E Palmetto Park Rd, Suite 301 SE DECISION MADE: 18-SEP-23
Boca Raton FL 33432 510(k) STATEMENT
DEVICE: Intrisound™ Tuned Lumen® 155 Hearing Aids
Tuned Ltd 510(k) NO: K223848(Traditional)
ATTN: Orit lanco PHONE NO : 972 52 5705700
18 Harimon St SE DECISION MADE: 08-SEP-23
Gan Yoshiya IL 3885000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: i-STAT G3+ cartridge with the i-STAT 1 System
ABBOTT POINT OF CARE, INC 510(k) NO: K223857(Traditional)
ATTN: Jacquelyn Gesumaria PHONE NO : 609 4549384
400 College Road East SE DECISION MADE: 15-SEP-23
Princeton NJ 08540 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Alignment System Cranial, Alignment Software Cranial, Cirq Alignment Software Cranial Biopsy, Cirq Alignment Software Cranial sEEG, Varioguide Alignment Software Cranial
Brainlab AG 510(k) NO: K223864(Traditional)
ATTN: Esther Moreno Garcia PHONE NO : 49____ 8999 15680
Olof-Palme-Str.9 SE DECISION MADE: 09-SEP-23
Munich DE 81829 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ChoiceSpine Blackhawk Ti Cervical Spacer System
ChoiceSpine, LLC 510(k) NO: K223869(Traditional)
ATTN: Kim Finch PHONE NO : 865 2463969___
400 Erin Drive SE DECISION MADE: 14-SEP-23
Knoxville TN 37919 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Boppli Infant Blood Pressure Monitor
PyrAmes Inc. 510(k) NO: K223873(Traditional)
ATTN: Xina Quan PHONE NO : 408 5695215___
21730 Stevens Creek Blvd., Suite 2SE DECISION MADE: 29-SEP-23
Cupertino CA 95014 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HOPKINS Telescopes
Karl Storz Endoscopy America, Inc.510(k) NO: K223885(Traditional)
ATTN: Jordan Lydia Verla PHONE NO : 424 2188100 8382
2151 E. Grand Ave SE DECISION MADE: 14-SEP-23
El Segundo CA 90245 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ApneaRX Pro
Apnea Sciences Coporation 510(k) NO: K223901(Special)
ATTN: James Fallon PHONE NO : 949 6802771
27121 Aliso Creek Road, Bldg 140 SE DECISION MADE: 01-SEP-23
Aliso Viejo CA 92656 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Socrates Aspiration System
Scientia Vascular Inc 510(k) NO: K223913(Traditional)
ATTN: Thomas Lippert PHONE NO : 888 3859016
3487 West 2100 South Suite 100 SE DECISION MADE: 20-SEP-23
West Valley City UT 84119 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: B.Light Clear Evo and B.Light Restore Evo
Bemer INT. AG 510(k) NO: K223919(Traditional)
ATTN: Sandra Schwarzenberger PHONE NO : 423 3993999
Austrasse 15 SE DECISION MADE: 23-SEP-23
Triesen LI 9495 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Access CEA
Beckman Coulter, Inc 510(k) NO: K223921(Traditional)
ATTN: Abhi Kannan PHONE NO : 190 555 60843
1000 Lake Hazeltine Drive SE DECISION MADE: 22-SEP-23
Chaska MN 55318 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Exactech Equinoxe PHx Fracture System; Exactech EPIC Screws
Exactech, Inc 510(k) NO: K223933(Traditional)
ATTN: Valdimir Talley PHONE NO : 352 3274824
2320 NW 66th Ct. SE DECISION MADE: 25-SEP-23
Gainesville FL 32653 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Mpact Extension
Medacta International S .A. 510(k) NO: K230011(Traditional)
ATTN: Stefano Baj PHONE NO : 41 91 6966060
Strada Regina SE DECISION MADE: 20-SEP-23
Castel San Pietro CH CH-6874 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HI-EMT MAGSHAPE
Beijing Sano Laser S&T Development510(k) NO: K230024(Traditional)
ATTN: Hongbo Zhang PHONE NO : 86 10 53006037 830
Room 7-201, No.1, Caida 3rd StreetSE DECISION MADE: 06-SEP-23
Bejing CN 010-57150601 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Insulin Pen Needle
Anhui Hongyu Wuzhou Medical Manufa510(k) NO: K230043(Traditional)
ATTN: Bingyi Xiang PHONE NO : 86 556 5129666
No.2 Guanyin Road, Taihu Economic SE DECISION MADE: 20-SEP-23
Anqing CN 246400 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HipCheck
Stryker Corp. 510(k) NO: K230045(Traditional)
ATTN: Lucas Dun PHONE NO : 303 9312353
5900 Optical Ct SE DECISION MADE: 29-SEP-23
San Jose CA 95138 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SKORE Smooth, Dotted, Thin Condoms - SKORE Blues, SKORE Belgian Chocolate, SKORE Dots, SKORE NOTHING Strawberry, SKORE NOTHING Chocolate, SKORE SKIN THIN Ultra fine; SKORE Bulbous Condoms - SKORE WARM, SKORE COOL; SKORE Benzocaine Condoms - SKORE NOTHING Climax Delay, SKORE DUO MAX, SKORE NOT OUT
TTK Healthcare Limited 510(k) NO: K230049(Traditional)
ATTN: Daniel J S PHONE NO : 91 413 2261401
12, K P Natham Road, Thiruvandar KSE DECISION MADE: 07-SEP-23
Puducherry IN 605102 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Carnation series Diagnostic Ultrasound System
Shenzhen Wisonic Medical Technolog510(k) NO: K230066(Traditional)
ATTN: Jiang Xiaosan PHONE NO : 86 755 86007788
1st, 2nd, 5th & 6th Floor, No. 6 BSE DECISION MADE: 15-SEP-23
Shenzhen CN 518055 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Para-Fix External Fixation System
New Paradigm Biomedical 510(k) NO: K230067(Traditional)
ATTN: John Wixted PHONE NO : 1 781 5499008
163 Highland Ave #1144 SE DECISION MADE: 22-SEP-23
Needham MA 02494 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Smart double sides wearable breast pump, Electric bilateral breast pump
Huizhou LVB Maternal And Infant Su510(k) NO: K230102(Traditional)
ATTN: Dongan Zhang PHONE NO : 86 130 75210606
Block A 16 Huifengxi 3rd,Pingnan ISE DECISION MADE: 21-SEP-23
Huizhou CN 516000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Straumann® BLC and TLC Implants
Institut Straumann AG 510(k) NO: K230108(Traditional)
ATTN: Corinne Arimatea PHONE NO : 41 61 9651217___
Peter Merian Weg 12 SE DECISION MADE: 14-SEP-23
Basel CH CH-4002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Biliary Plastic Stent, Biliary Plastic Stent Introducer, Biliary Plastic Stent Set, Biliary Plastic Stent Introducer/ short-wire compatible, Biliary Plastic Stent Set/ short-wire compatible
Micro-Tech (Nanjing) Co., Ltd. 510(k) NO: K230127(Traditional)
ATTN: Sally He PHONE NO : 86 25 58646395
No.10 Gaoke Third Road, Nanjing NaSE DECISION MADE: 06-SEP-23
Nanjing CN 210032 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BACK 4
SWIMS America Corp 510(k) NO: K230167(Traditional)
ATTN: Matthieu Commeau PHONE NO : 917 3717388___
1133 Westchester Avenue Suite N 22SE DECISION MADE: 14-SEP-23
White Plains NY 10604 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Holter ECG and ABP System
Edan Instruments, Inc. 510(k) NO: K230184(Traditional)
ATTN: Lavender Wang PHONE NO : 86____ 755 26858736
#15 Jinhui Road,Jinsha Community, SE DECISION MADE: 25-SEP-23
Shenzhen CN 518122 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Terran NM-101
Terran Biosciences, Inc. 510(k) NO: K230187(Traditional)
ATTN: Sam Clark PHONE NO : 571 2431490
507 W. 28th Street PH 3A SE DECISION MADE: 29-SEP-23
New York NY 10001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Servator P Plus SALF Solution
S.A.L.F. spa 510(k) NO: K230193(Traditional)
ATTN: Carmelo Gagliano PHONE NO : 39 035 940097
Via Marconi 2 SE DECISION MADE: 21-SEP-23
Cenate Sotto IT 24069 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Integrity-SI® Fusion System
OsteoCentric Technologies 510(k) NO: K230226(Special)
ATTN: Todd Evans PHONE NO : 435 7572253
75 West 300 N., Suite 150 SE DECISION MADE: 21-SEP-23
Logan UT 84321 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Dental Braces (Model: HK-Y-0.4, HK-Y-0.45, HK-Y-0.63, HK-Y-0.7, HK-Y-ST-0.76, HK-Y-CF-0.76, HK-Y-0.9, HK-Y-1.0, HK-Y-2.0)
Hkable 3D Biologic Printing Techno510(k) NO: K230237(Traditional)
ATTN: Chen Yang PHONE NO : 86 134 52333376
3-3, No. 10, Tiangui Road, Mudong SE DECISION MADE: 14-SEP-23
Chongqing CN 401338 510(k) STATEMENT
DEVICE: AirSeal iFS System; AirSeal dV Solution
CONMED Corporation 510(k) NO: K230239(Traditional)
ATTN: Tina Mornak PHONE NO : 724 5183191
525 French Road SE DECISION MADE: 20-SEP-23
Utica NY 13502 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OFIX MIS App
Orthofix US LLC 510(k) NO: K230252(Traditional)
ATTN: Shant Aghyarian PHONE NO : 469 3941155
3451 Plano Parkway SE DECISION MADE: 26-SEP-23
Lewisville TX 75056 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STAT Medical Device Lancing System
STAT Medical Devices 510(k) NO: K230310(Traditional)
ATTN: Hemel Mariano PHONE NO : 305 9450011 312___
2056 N.E. 153rd Street SE DECISION MADE: 08-SEP-23
North Miami Beach FL 33162 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Elos Accurate Hybrid Base
Elos Medtech Pinol A/S 510(k) NO: K230317(Traditional)
ATTN: Lise Terkelsen PHONE NO : 45 216 11225
Engvej 33 SE DECISION MADE: 01-SEP-23
Goerloese DK 3330 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ambu® aScope™ Colon; Ambu® aBox™ 2
Ambu A/S 510(k) NO: K230332(Traditional)
ATTN: Mette Andersen PHONE NO : 45 538 13820
Baltorpbakken 13 SE DECISION MADE: 15-SEP-23
Ballerup DK 2750 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VISULAS yag
Carl Zeiss Meditec Inc 510(k) NO: K230350(Traditional)
ATTN: Tanesha Bland PHONE NO : 1 925 2167963
5300 Central Parkway SE DECISION MADE: 22-SEP-23
Dublin CA 94568 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Planar LED mate
Shenzhen Leaflife Technology Co., 510(k) NO: K230362(Traditional)
ATTN: Cheng Qiang PHONE NO : 086 0178 75910506
4F, Bldg. C, JMD Industrial Park, SE DECISION MADE: 11-SEP-23
Shenzhen CN 518116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VitreJect Syringe
OcuJect, LLC 510(k) NO: K230372(Traditional)
ATTN: Leonid Lerner PHONE NO : 949 7216716
1441 Avocado Ave, Suite 204 SE DECISION MADE: 08-SEP-23
Newport Beach CA 92660 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MedCAD® AccuPlate® 3DTi Patient-Specific Plating System
MedCAD 510(k) NO: K230398(Traditional)
ATTN: Brian Buss PHONE NO : 214 4538864
501 S 2nd Ave, Suite A-1000 SE DECISION MADE: 26-SEP-23
Dallas TX 75226 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BTL-899F
BTL Industries Inc. 510(k) NO: K230467(Traditional)
ATTN: David Chmel PHONE NO : 1 866 2851656
362 Elm Street SE DECISION MADE: 21-SEP-23
Marlborough MA 01752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Passy Muir Tracheostomy Viral & Bacterial Airway Protection Filter (PM-APF15)
Passy-Muir, Inc. 510(k) NO: K230483(Third Party - Traditional)
ATTN: Donna Malter PHONE NO : 949 8338255
17992 Mitchell So., Suite 200 SE DECISION MADE: 16-SEP-23
Irvine CA 92614 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: Arthrex Univers Apex OptiFit Humeral Stem
Arthrex Inc 510(k) NO: K230513(Traditional)
ATTN: Tiffany Mentzel PHONE NO : 1 239 6435553 75833
1370 Creekside Boulevard SE DECISION MADE: 26-SEP-23
Naples FL 34108-1945 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Legends Orthopedics Suture Anchors (Legends Orthopedics 5.5 mm Suture Anchors, Legends Orthopedics 2.9 mm Suture Anchor, and Legends Orthopedics 5.5 mm Knotless Suture Anchor)
Jarmon Medical, LLC (DBA Legends O510(k) NO: K230517(Traditional)
ATTN: Jeremy Jarmon PHONE NO : 800 7413995
169 E Reynolds Road, Suite 203B SE DECISION MADE: 11-SEP-23
Lexington KY 40517 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TEA Device
Transtimulation Research, Inc. 510(k) NO: K230526(Traditional)
ATTN: Jieyun Yin PHONE NO : 832 2027068
800 Research Parkway, Suite 337 SE DECISION MADE: 14-SEP-23
Oklahoma City OK 73104 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KARL STORZ Urological Laser Accessories
Karl Storz SE & CO. KG 510(k) NO: K230535(Traditional)
ATTN: Alita McElroy PHONE NO : 424 2188376
Dr.-Karl-Storz-Straße 34 Baden-WurSE DECISION MADE: 08-SEP-23
Tuttlingen DE 78532 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EVOLUTION® Hinge Knee System
MicroPort Orthopedics Inc. 510(k) NO: K230563(Traditional)
ATTN: Ryan Ross PHONE NO : 901 8674401
5677 Airline Road SE DECISION MADE: 27-SEP-23
Arlington TN 38002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TriLEAP Plating System
CrossRoads Extremity Systems 510(k) NO: K230591(Traditional)
ATTN: Keith Knapp PHONE NO : 215 2608760
6423 Shelby View Dr., Suite 101 SE DECISION MADE: 29-SEP-23
Memphis TN 38134 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Stone Extraction Baskets
Jiangsu Vedkang Medical Science an510(k) NO: K230598(Traditional)
ATTN: Qian Wen PHONE NO : 86 519 69877792
No.52, Guoxiang Road, Wujin EconomSE DECISION MADE: 12-SEP-23
Changzhou CN 213149 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NG Delivery Catheter
Balt USA, LLC 510(k) NO: K230609(Traditional)
ATTN: Catherine Chiou PHONE NO : 562 2863057
29 Parker SE DECISION MADE: 13-SEP-23
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KITE Distal Fibula Kit
Intrauma S.p.A 510(k) NO: K230623(Traditional)
ATTN: Piero Costa PHONE NO : 39 011 9539496
Via Genova 19 SE DECISION MADE: 01-SEP-23
Rivoli (TO) IT 10098 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Signum opaque F
Kulzer, LLC 510(k) NO: K230644(Traditional)
ATTN: David Vincent PHONE NO : 574 2995421
4315 S. Lafayette Blvd SE DECISION MADE: 07-SEP-23
South Bend IN 46614 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Arm Blood Pressure Monitor
Alicn Medical Shenzhen, Inc 510(k) NO: K230649(Traditional)
ATTN: Fang Meisong PHONE NO : 86 755 26501548
Room 410,Building A,3rd Sub-park,LSE DECISION MADE: 07-SEP-23
Shenzhen CN 518118 510(k) STATEMENT
DEVICE: Zeta Cranial Navigation System
Zeta Surgical 510(k) NO: K230661(Traditional)
ATTN: Jose Amich PHONE NO : 857 2725703
2 Park Plaza, Suite 400 SE DECISION MADE: 08-SEP-23
Boston MA 02116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TULSA-PRO System
Profound Medical Inc. 510(k) NO: K230692(Traditional)
ATTN: Nicole Baker PHONE NO : 1 647 4761350 414
2400 Skymark Avenue, Unit 6 SE DECISION MADE: 20-SEP-23
Mississauga CA L4W 5K5 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ultimate rTMS; Yingchi rTMS
Brain Ultimate, Inc. 510(k) NO: K230735(Traditional)
ATTN: Frank Ge PHONE NO : 770 3786785
1185 Park Glenn Drive SE DECISION MADE: 13-SEP-23
Alpharetta GA 300005 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ICHOR 14F Embolectomy System
ICHOR 510(k) NO: K230743(Traditional)
ATTN: Angela Mallery PHONE NO : 651 2104766
1900 NW 25th St. SE DECISION MADE: 05-SEP-23
Boca Raton FL 33431 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Non absorbable Surgical Polypropylene Suture
Shandong Haidike Medical Products 510(k) NO: K230746(Traditional)
ATTN: Yan Wang PHONE NO : 86 530 4660062
Tianfu Road, Dongcheng District, SSE DECISION MADE: 14-SEP-23
Heze CN 274300 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OSSIOfiber® Cannulated Trimmable Fixation Nail
Ossio Ltd. 510(k) NO: K230750(Traditional)
ATTN: Taly Lindner PHONE NO : 972 4 9986600
8 HaTochen St. SE DECISION MADE: 13-SEP-23
Caesarea IL 3079861 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Over-tube (TR-1208A); Over-tube (TR-1504A); Over-tube (TR-1507A)
Fujifilm Healthcare Americas Corpo510(k) NO: K230752(Traditional)
ATTN: Kotei Aoki PHONE NO : 765 2462931
81 Hartwell Avenue Suite 300 SE DECISION MADE: 15-SEP-23
Lexington MA 02421 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Pelvic Floor Muscle Stimulator
Nanjing Vishee Medical Technology 510(k) NO: K230767(Traditional)
ATTN: Qiu Kai PHONE NO : 86 025 696708
Building 9, No.19, Ningshuang RoadSE DECISION MADE: 21-SEP-23
Nanjing CN 210012 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SOFIA EX Intracranial Support Catheter
MicroVention, Inc. 510(k) NO: K230775(Traditional)
ATTN: Miranda Beach PHONE NO : 949 9890580
35 Enterprise SE DECISION MADE: 14-SEP-23
Aliso Viejo CA 92656 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EndoCore
Praxis Medical, LLC 510(k) NO: K230778(Traditional)
ATTN: John Fisher PHONE NO : 727 4821602
500 N Willow Ave. Ste 101 SE DECISION MADE: 25-SEP-23
Tampa FL 33606 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TriMed Clavicle Fixation System
TriMed, Inc. 510(k) NO: K230805(Traditional)
ATTN: David Medoff PHONE NO : 661 2557406
27533 Avenue Hopkins SE DECISION MADE: 01-SEP-23
Santa Clarita CA 91355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IntelliWave3, Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A)
Art Optical Contact Lens, Inc. 510(k) NO: K230824(Traditional)
ATTN: Jill Anastor PHONE NO : 630 5309700
3175 3 Mile Road NW SE DECISION MADE: 06-SEP-23
Walker MI 49534 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Smileyscope System (Therapy Mode)
Smileyscope Holding Inc. 510(k) NO: K230825(Traditional)
ATTN: Paul Leong PHONE NO : 1 888 3007117
701 Tillery Street #12 SE DECISION MADE: 25-SEP-23
Austin TX 78702 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Chemotherapy Gloves
3A Glove Sdn. Bhd. 510(k) NO: K230847(Traditional)
ATTN: Kumar Durarajen PHONE NO : 60 127 135040
PTD 2058 & 2059, Jalan Cyber 4 KawSE DECISION MADE: 29-SEP-23
Senai MY 81400 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TiLink-P SI Joint Fusion System
Surgentec, LLC 510(k) NO: K230857(Traditional)
ATTN: Andrew Shoup PHONE NO : 561 9907882
911 Clint Moore Rd SE DECISION MADE: 25-SEP-23
Boca Raton FL 33487 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PIVO™ Pro Needle-free Blood Collection Device
Becton Dickinson Infusion Therapy 510(k) NO: K230865(Traditional)
ATTN: Amy Moore PHONE NO : 801 5225000
9450 S State St SE DECISION MADE: 28-SEP-23
Sandy UT 84070 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Change Healthcare Cardiology Hemodynamics™
Change Healthcare Israel Ltd. 510(k) NO: K230881(Traditional)
ATTN: Alona Golik PHONE NO : 972 52 4084942
26 Harokmim St. SE DECISION MADE: 11-SEP-23
Holon IL 5885849 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AVVIGO'"+ Multi-Modality Guidance System
Boston Scientific Corporation 510(k) NO: K230884(Traditional)
ATTN: Kevin Catalano PHONE NO : 612 8172987
Two Scimed Place SE DECISION MADE: 26-SEP-23
Maple Grove MN 55311 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ISE Electrodes
Randox Laboratories Ltd. 510(k) NO: K230890(Special)
ATTN: Karena Shaw PHONE NO : 44 028 94422413
55 Diamond Road SE DECISION MADE: 08-SEP-23
Crumlin GB BT29 4QY 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MasterX 800 Series
Medicatech USA 510(k) NO: K230918(Traditional)
ATTN: George Makar PHONE NO : 949 6792881
50 Maxwell SE DECISION MADE: 01-SEP-23
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Injection Needle AF series
Alton (Shanghai) Medical Instrumen510(k) NO: K230925(Traditional)
ATTN: Vivian Li PHONE NO : 86 215 6771811
No.24 Building Jinshao Rd. 1688.BaSE DECISION MADE: 27-SEP-23
Shanghai CN 200949 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression Screw System-Medium Product Code ACC-M; Accelerate Compression Screw System-Large Product Code ACC-L
Trax Surgical 510(k) NO: K230946(Traditional)
ATTN: Steven Tallarida PHONE NO : 781 8284400
75 Mill Street SE DECISION MADE: 15-SEP-23
Stoughton MA 02072 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VitreJect® Needle; OcuSafe® Needle
OcuJect, LLC 510(k) NO: K230959(Traditional)
ATTN: Leonid Lerner PHONE NO : 949 7216716
1441 Avocado Ave, Suite 204 SE DECISION MADE: 14-SEP-23
Newport Beach CA 92660 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: angiOCCLUDE Ligating Clips
A2 Medical Systems, LLC 510(k) NO: K230966(Traditional)
ATTN: Robert Hall PHONE NO : 919 5382325
6387 Technology Ave. SE DECISION MADE: 19-SEP-23
Kalamazoo MI 49009 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NIDO™ Pedicle Screw System
Kalitec Medical 510(k) NO: K230974(Traditional)
ATTN: Keith Cannon PHONE NO : 407 5452063
618 E. South Street, Suite 500 SE DECISION MADE: 15-SEP-23
Orlando FL 32801 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MicroMatrix® Flex
ACell, Inc. 510(k) NO: K230980(Traditional)
ATTN: Simone Oliver PHONE NO : 301 7895682
6640 Eli Whitney Drive Suite 200 SE DECISION MADE: 22-SEP-23
Columbia MD 21046 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FlowStar Analog Mixer Flowmeter
Baldus Sedation GmbH & Co. KG 510(k) NO: K230987(Traditional)
ATTN: Lisa Baldus PHONE NO : 49 261 963892666
In der Langfuhr 32 SE DECISION MADE: 14-SEP-23
Bendorf DE 56170 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CEDIA Heroin Metabolite (6-AM) Assay
Microgenics Corporation 510(k) NO: K231007(Traditional)
ATTN: Amrit Takhar PHONE NO : 510 9795000
46500 Kato Road SE DECISION MADE: 27-SEP-23
Fremont CA 94538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Merilas 532 shortpulse, Merilas 577 shortpulse, Merilas 810 shortpulse
Meridian AG 510(k) NO: K231011(Traditional)
ATTN: Eric Odenheimer PHONE NO : 41 0_____ 333341111
Bierigutstrasse 7 SE DECISION MADE: 12-SEP-23
Thun CH CH-3608 510(k) STATEMENT
DEVICE: DNA/RNA Shield SafeCollect Saliva Collection kit
Zymo Research 510(k) NO: K231013(Traditional)
ATTN: Julie Ogi PHONE NO : 949 6791190
17062 Murphy Ave SE DECISION MADE: 28-SEP-23
Irvine CA 92614 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cove Putty, OsteoCove Putty
SeaSpine Orthopedics Corporation 510(k) NO: K231030(Traditional)
ATTN: Cindy Toyama PHONE NO : 949 8557175
2 Goodyear SE DECISION MADE: 14-SEP-23
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UniSyn Molecular Imaging (6-3-1)
Convergent Imaging Solutions 510(k) NO: K231047(Traditional)
ATTN: Mathew Thomas PHONE NO : 1 613 212 0063
36 Rideau River Lane SE DECISION MADE: 01-SEP-23
Ottawa CA K1S 0X1 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VariLift®-C Interbody Fusion System
Wenzel Spine, Inc. 510(k) NO: K231076(Traditional)
ATTN: William Wilson PHONE NO : 512___ 4690600
1130 Rutherford Lane Suite 200 SE DECISION MADE: 27-SEP-23
Austin TX 78753 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LW Retraction Cap
Ossvis Co., Ltd. 510(k) NO: K231079(Traditional)
ATTN: Young Jae Kim PHONE NO : 82 31 3600082
7F and B1, 38, Burim-ro 170beon-giSE DECISION MADE: 14-SEP-23
Anyang-si KR 14055 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: T-SHAPE 2
B&M S.R.L. Marketing Nel Benessere510(k) NO: K231092(Traditional)
ATTN: Brando Baldan PHONE NO : 39 348 2322067
Via Leonardo Bruni, 25 SE DECISION MADE: 22-SEP-23
Milano IT 20158 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Accuject Refra Injector AR2900
Medicel AG 510(k) NO: K231106(Traditional)
ATTN: Erik Braziulis PHONE NO : 41 717 270947
Dornierstrasse 11 SE DECISION MADE: 19-SEP-23
Altenrhein CH 9423 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Talon Transseptal Sheath
Inari Medical, Inc. 510(k) NO: K231108(Traditional)
ATTN: Ellen Nguyen PHONE NO : 949 4184127
6001 Oak Canyon Suite 100 SE DECISION MADE: 27-SEP-23
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner
Materialise NV 510(k) NO: K231112(Traditional)
ATTN: Giulia Girola PHONE NO : 32 16 396611
Technologielaan 15 SE DECISION MADE: 12-SEP-23
Leuven BE 3001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STarFix Designer Software C0265
FHC, Inc. 510(k) NO: K231141(Traditional)
ATTN: Kelly Moeykens PHONE NO : 207 6668190
1201 Main Street SE DECISION MADE: 08-SEP-23
Bowdoin ME 04287 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AliTight
Alic Iotech, LLC 510(k) NO: K231146(Traditional)
ATTN: Like Zeng PHONE NO : 520 9071679
8165 Mountain View Dr Unit D SE DECISION MADE: 08-SEP-23
Pleasanton CA 94588 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Hammerdesis™ Interphalangeal Fusion System
Intelivation 510(k) NO: K231147(Traditional)
ATTN: David Posillico PHONE NO : 912 4342780
500 S Gravers Rd Suite 200 SE DECISION MADE: 14-SEP-23
Plymouth Meeting PA 19462 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: qXR-CTR
Qure.ai Technologies 510(k) NO: K231149(Traditional)
ATTN: Srinidhi Ragunathan PHONE NO : 91 22 68505800
Level 7, Commerz II, InternationalSE DECISION MADE: 22-SEP-23
Mumbai IN 400063 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALIGN Radial Head System
Skeletal Dynamics Inc 510(k) NO: K231188(Traditional)
ATTN: Alexandra Rodriguez Rojas PHONE NO : 305 5967585
7300 North Kendall Drive SE DECISION MADE: 28-SEP-23
Miami FL 33156 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CARTO™ 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U)
Biosense Webster, Inc. 510(k) NO: K231207(Traditional)
ATTN: Caleb Lau PHONE NO : 949 7041584
31 Technology Drive, Suite 200 SE DECISION MADE: 07-SEP-23
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LW UCLA Abutment
Ossvis Co., Ltd. 510(k) NO: K231235(Traditional)
ATTN: Young Jae Kim PHONE NO : 82 31 3600082
7F and B1, 38, Burim-ro 170beon-giSE DECISION MADE: 15-SEP-23
Anyang-si KR 14055 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nexiva™ Closed IV Catheter System with NearPort™ IV Access
Becton Dickinson Infusion Therapy 510(k) NO: K231239(Traditional)
ATTN: Paul Holman PHONE NO : 801 8343607
9450 South State Street SE DECISION MADE: 22-SEP-23
Sandy UT 84070 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MaxTack™ Motorized Fixation Device
Covidien 510(k) NO: K231240(Traditional)
ATTN: Megha Patel PHONE NO : 917 6649611
60 Middletown Avenue SE DECISION MADE: 08-SEP-23
North Haven CT 06473 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Perifix FX Catheter; Contiplex FX Catheter
B. Braun Medical Inc. 510(k) NO: K231242(Traditional)
ATTN: Tracy Larish PHONE NO : 484 3759064
3773 Corporate Parkway SE DECISION MADE: 15-SEP-23
Center Valley PA 18034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced Monitoring Platform
Edwards Lifesciencess LLC 510(k) NO: K231248(Traditional)
ATTN: Anne Lo PHONE NO : 949 2503386
One Edwards Way SE DECISION MADE: 21-SEP-23
Irvine CA 92614 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Montage Flowable Settable, Resorbable Bone Paste
Orthocon, Inc. 510(k) NO: K231270(Traditional)
ATTN: Aniq Darr PHONE NO : 855 4759175
700 Fairfield Avenue Suite 1 SE DECISION MADE: 01-SEP-23
Stamford CT 06902 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Aquilion Serve (TSX-307A/1) V1.3
Canon Medical Systems Corporation 510(k) NO: K231281(Traditional)
ATTN: Paul Biggins PHONE NO : 714 6697808
1385 Shimoishigami SE DECISION MADE: 19-SEP-23
Otawara-shi JP 324-8550 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SiteRite™ 9 Ultrasound System
Bard Access Systems, Inc. (C.R. Ba510(k) NO: K231283(Traditional)
ATTN: Fabio De Pasquale PHONE NO : 1 250 9206501
605 North 5600 West SE DECISION MADE: 11-SEP-23
Salt Lake City UT 84116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OnPoint Augmented Reality Spine System
OnPoint Surgical, Inc. 510(k) NO: K231284(Traditional)
ATTN: Amy ODonnell PHONE NO : 585 8800356
19 Crosby Drive, Suite 120 SE DECISION MADE: 08-SEP-23
Bedford MA 01730 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TrueBeam, TrueBeam STx, Edge, VitalBeam
Varian Medical Systems, Inc. 510(k) NO: K231317(Traditional)
ATTN: Peter J. Coronado PHONE NO : 650 4245728
3100 Hansen Way SE DECISION MADE: 12-SEP-23
Palo Alto CA 94304 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cleerly ISCHEMIA
Cleerly, Inc 510(k) NO: K231335(Traditional)
ATTN: Candice Bautista-Biddle PHONE NO : 917 6717746
110 16th Steet Suite 1400 #104 SE DECISION MADE: 08-SEP-23
Denver CO 80218 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: T2 Biothreat Panel
T2 Biosystems, Inc. 510(k) NO: K231336(Traditional)
ATTN: Rachel Gilbert PHONE NO : 781 2262767 1970
101 Hartwell Avenue SE DECISION MADE: 15-SEP-23
Lexington MA 02421 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Insufflator (OPTO-IFL1000)
Guangdong OptoMedic Technologies, 510(k) NO: K231342(Traditional)
ATTN: Weijuan Guo PHONE NO : 07 578 6702920
Suite 503, Building A, Golden VallSE DECISION MADE: 20-SEP-23
Foshan CN 528200 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AccuCTP Pro
ArteryFlow Technology Co., Ltd. 510(k) NO: K231353(Special)
ATTN: Jianping Xiang PHONE NO : 86 571 86772567
459 Qianmo Road, Suite C1-501, BinSE DECISION MADE: 14-SEP-23
Hangzhou CN 310051 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Hantech Pre-filled 0.9% Normal Saline Flush Syringes (Models PFS-1003, PFS-1005, PFS-1010)
Hantech Medical Device Co., Ltd. 510(k) NO: K231363(Traditional)
ATTN: Arnold Yang PHONE NO : 86 180 58297039
No 288 Sanheng Road, Changhe IndusSE DECISION MADE: 27-SEP-23
Ningbo CN 315326 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Wrist Electronic Blood Pressure Monitor(Model FC-BP200, FC-BP201, FC-BP210,FC-BP211, FC-BP220, FC-BP221)
Shenzhen Finicare Co., Ltd. 510(k) NO: K231367(Traditional)
ATTN: Chao Li PHONE NO : 86 755 23013503
201, No.50, the 3rd Industrial ParSE DECISION MADE: 18-SEP-23
Shenzhen CN 518104 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Annalise Enterprise CTB Triage Trauma
Annalise-AI Pty Ltd. 510(k) NO: K231384(Traditional)
ATTN: Haylee Bosshard PHONE NO : 61 493 266602
Level P, 24 Campbell St. SE DECISION MADE: 22-SEP-23
Sydney AU 2000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Rology Teleradiology Platform (v.1.22.1103)
Rology Inc. 510(k) NO: K231385(Traditional)
ATTN: Amr Abodraiaa PHONE NO : 302 5619511
1202 NE McCain Road Bldg 7 SE DECISION MADE: 20-SEP-23
Bentonville AR 72712 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Polysafety BC, Polysafety BC Adva, Polywin Safety, Polywin Safety Adva
Poly Medicure Limited 510(k) NO: K231401(Traditional)
ATTN: Ramdas Sharma PHONE NO : 91 98733 80144
Plot No. 115-116, Sector-59, HSIIDSE DECISION MADE: 21-SEP-23
Faridabad IN 121004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Single-Use Latex Sterile Surgical Gloves (SG100)
Fitone Latex Products Co., Ltd. Gu510(k) NO: K231446(Traditional)
ATTN: Christine Ou PHONE NO : 0759 7905808
No.5 Huitong road, Lingbei IndustrSE DECISION MADE: 22-SEP-23
Zhanjiang CN 524338 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Air/Water Bottle Tubing, CO2 Source Tubing
Zhejiang Chuangxiang Medical Techn510(k) NO: K231471(Traditional)
ATTN: Lucius Long PHONE NO : 86 571 89167088
Room 101,201,301,401,501, BuildingSE DECISION MADE: 08-SEP-23
Hangzhou CN 311100 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TriALTIS Spine System
Medos International SARL 510(k) NO: K231479(Traditional)
ATTN: Megan Smith PHONE NO : 978 5388797
Chemin-Blanc 38 SE DECISION MADE: 22-SEP-23
LeLocle CH 2400 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PureWay 1.4 Quart Sharps Collector
PureWay Compliance Inc. 510(k) NO: K231484(Traditional)
ATTN: Jeffery Miglicco PHONE NO : 713 2482289
201 Santa Monica Blvd, Suite 400 SE DECISION MADE: 14-SEP-23
Santa Monica CA 90401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TITANEX™ MICROBEAM Screw System, TITANEX™ ARTEMIS Screw System
Vilex LLC 510(k) NO: K231504(Traditional)
ATTN: Brock Johnson PHONE NO : 801 9164157
111 Moffitt Street SE DECISION MADE: 11-SEP-23
McMinnville TN 37110 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TriALTIS Navigation Enabled Instruments
Medos International SÀRL 510(k) NO: K231527(Traditional)
ATTN: Nicole Aeschbacher PHONE NO : 41 61 5641798
Chemin-Blanc 38 SE DECISION MADE: 29-SEP-23
LeLocle CH 2400 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FreedomFlow Orbital Circumferential Atherectomy System
Cardio Flow, Inc. 510(k) NO: K231538(Traditional)
ATTN: Michael J. Kallok PHONE NO : 800 2945517
3530 88th Ave NE SE DECISION MADE: 27-SEP-23
Blaine MN 55014 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Digital Blood Pressure Monitor WBP Series
Weony (Shenzhen) Technology Co., L510(k) NO: K231542(Traditional)
ATTN: Autumn Liu PHONE NO : 86 755 86057437__
401, the 6th building, Changfeng ISE DECISION MADE: 07-SEP-23
Shenzhen CN 518132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: cNeuro cPET
Combinostics Oy 510(k) NO: K231576(Traditional)
ATTN: Thurfjell Lennart PHONE NO : 46 730 699057
Hatanpään valtatie 24 SE DECISION MADE: 14-SEP-23
Tampere FI 33100 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REGER Nebulizer Irrigation Cannula
REGER Medizintechnik, GmbH 510(k) NO: K231622(Traditional)
ATTN: Christopher Kohn PHONE NO : 49 741 2706980
Gewerbestrasse 10 SE DECISION MADE: 29-SEP-23
Villingendorf DE 78667 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BeShape One™ Device
BeShape Technologies Ltd. 510(k) NO: K231628(Traditional)
ATTN: Amit Goren PHONE NO : 972 9 7670002
23 Hatas St. SE DECISION MADE: 29-SEP-23
Kfar-Saba IL 4442525 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue)
Syntex Healthcare Products Co., Lt510(k) NO: K231643(Traditional)
ATTN: Qiao Zhiqiang PHONE NO : 86 311 66179668
No. 1, Fanjiazhuang Industrial ZonSE DECISION MADE: 08-SEP-23
Xinji CN 052360 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Intraosseous Fusion Device System
Auxano Medical LLC 510(k) NO: K231649(Traditional)
ATTN: Jennifer Hazou PHONE NO : 440 7174000
8006 Katherine Boulevard SE DECISION MADE: 29-SEP-23
Brecksville OH 44141 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: The AVEOtsd (Tongue Stabilizing Device) Mouthpiece
Innovative Health Technologies (NZ510(k) NO: K231663(Traditional)
ATTN: Chapman Philip PHONE NO : 64 217 49148
229 Mopray Pl SE DECISION MADE: 18-SEP-23
Dunedin NZ 9016 510(k) STATEMENT
DEVICE: Overjet Periapical Radiolucency Assist
Overjet, Inc 510(k) NO: K231678(Traditional)
ATTN: Deepthi Paknikar PHONE NO : 630 2011612
560 Harrison Ave #403 SE DECISION MADE: 21-SEP-23
Boston MA 02118 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Gradual Dental Zirconia Blank
Liaoning UPCERA CO., Ltd 510(k) NO: K231687(Traditional)
ATTN: Li Luo PHONE NO : 86 024 45565006
No.122 Xianghuai Road, Economic DeSE DECISION MADE: 07-SEP-23
Benxi CN 117004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ImPACT Version 4
ImPACT Applications, Inc. 510(k) NO: K231688(Traditional)
ATTN: Michael Zagorski PHONE NO : 1 412 5678400
2140 Norcor Ave., Suite 115 SE DECISION MADE: 16-SEP-23
Coralville IA 52241 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WiScope® Digital Cystoscope System, WiScope® Single-Use Digital Flexible Cystoscope, WiScope® Medical Tablet
OTU Medical Inc. 510(k) NO: K231702(Traditional)
ATTN: Geping Liu PHONE NO : 1 408 4619801
2847A Whipple Rd SE DECISION MADE: 29-SEP-23
Union City CA 94587 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OW100S
Softwave./TRT LLC 510(k) NO: K231710(Traditional)
ATTN: John Warlick PHONE NO :
251 Heritage Walk SE DECISION MADE: 01-SEP-23
Woodstock GA 30188 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IPL Home Use Hair Removal Device, Model(s): JD-TM002, JD-TM003, JD-TM012, JD-TM016, JD-TM022
Foshan Jindi Electric Appliance Co510(k) NO: K231717(Traditional)
ATTN: Zhaozhi Li PHONE NO : 86 1831 6578883
No.13 Baiye Avenue, Xiqiao ScienceSE DECISION MADE: 06-SEP-23
Foshan CN 528211 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sterile Hypodermic Needles for Single Use
Wepon Medical Technology Co., Ltd.510(k) NO: K231720(Traditional)
ATTN: Di Zhao PHONE NO : 928 5922380
Floor 4, Building A, No. 58, JinhuSE DECISION MADE: 08-SEP-23
Wenling CN 317500 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sterile Safety Hypodermic Needles for Single Use
Wepon Medical Technology Co., Ltd.510(k) NO: K231723(Traditional)
ATTN: Di Zhao PHONE NO : 928 5922380___
Floor 4, Building A, No. 58, JinhuSE DECISION MADE: 08-SEP-23
Wenling CN 317500 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sterile Auto-Disable Syringes with/without Needle for Single Use
Wepon Medical Technology Co., Ltd.510(k) NO: K231727(Traditional)
ATTN: Di Zhao PHONE NO : 928 5922380
Floor 4, Building A, No. 58, JinhuSE DECISION MADE: 08-SEP-23
Wenling CN 317500 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sterile syringes for single use with/without needle
Wepon Medical Technology CO., Ltd.510(k) NO: K231729(Traditional)
ATTN: Di Zhao PHONE NO : 928 59 22380
Floor 4, Building A, No. 58, JinhuSE DECISION MADE: 08-SEP-23
Wenling CN 317500 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FemaSeed Intratubal Insemination
Femasys Inc. 510(k) NO: K231730(Traditional)
ATTN: Christine Thomas PHONE NO : 770 5003910 137
3950 Johns Creek CT. SE DECISION MADE: 22-SEP-23
Suwanee GA 30024 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cervical Spine Truss System (CSTS)
4Web Medical, Inc. 510(k) NO: K231739(Traditional)
ATTN: Lewis Harrison PHONE NO : 972 3100736
2801 Network Blvd. Suite 620 SE DECISION MADE: 25-SEP-23
Frisco TX 75034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VERIFY Spore Test Strip for S40 Sterilant Concentrate
Steris Corporation 510(k) NO: K231746(Traditional)
ATTN: Gregory Land PHONE NO : 440 3927424
5960 Heisley Rd SE DECISION MADE: 11-SEP-23
Mentor OH 44060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cartesion Prime (PCD-1000A/3) V10.15
Canon Medical Systems Corporation 510(k) NO: K231748(Traditional)
ATTN: Paul Biggins PHONE NO : 714 6697808
1385 Shimoishigami SE DECISION MADE: 12-SEP-23
Otawara-shi JP 324-8550 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Skyway Anterior Cervical Plate System
Kyocera Medical Technologies, Inc.510(k) NO: K231766(Traditional)
ATTN: Joey Thompson PHONE NO : 909 5572360
1200 California Street Suite 210 SE DECISION MADE: 12-SEP-23
Redlands CA 92374 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Annalise Enterprise CTB Triage Trauma
Annalise-AI Pty Ltd 510(k) NO: K231767(Traditional)
ATTN: Haylee Bosshard PHONE NO : 614 93266602
Level P, 24 Campbell St SE DECISION MADE: 22-SEP-23
Sydney AU 2000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PENTO Nd:YAG and Alexandrite laser system
Ilooda Co,.Ltd. 510(k) NO: K231791(Traditional)
ATTN: Mason Moon PHONE NO : 82 31 2784660
9F, 25, Deokcheon-Ro 152beon-Gil, SE DECISION MADE: 15-SEP-23
Anyang-Si KR 14084 510(k) STATEMENT
DEVICE: VeriSafe Safety sterile syringes
Promisemed Hangzhou Meditech Co., 510(k) NO: K231792(Traditional)
ATTN: Zearou Yang PHONE NO : 86 571 88772985
No. 1388 Cangxing Street, CangqianSE DECISION MADE: 28-SEP-23
Hangzhou City CN 311121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IPL Hair Removal Device, Model(s): JP1, JR3, JR8, JR9
Shenzhen Qianyu Technology Co., Lt510(k) NO: K231800(Traditional)
ATTN: Guoyang Li PHONE NO : 86 150 99998872
Room 1002, Building A2, KeXing SciSE DECISION MADE: 07-SEP-23
Shenzhen CN 518057 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Millipede 088 Access Catheter
Perfuze Ltd. 510(k) NO: K231802(Special)
ATTN: Anne-Marie Gannon PHONE NO : 35 391 428083
Unit 6, Galway Business Park SE DECISION MADE: 19-SEP-23
Dangan IE H91 W7CP 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Quick-Start Orthopaedic Fixation Screw and Reverse Thread Screw
Innovate Orthopaedics Limited 510(k) NO: K231819(Traditional)
ATTN: Mike Bilson PHONE NO : 44 01484 796796
The Globe, Bridge Street, SlaithwaSE DECISION MADE: 05-SEP-23
Huddersfield GB HD7 5JN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BTI Dental Implant System UnicCa® – Aesthetic Post Abutments
B.T.I. Biotechnology Institute, S.510(k) NO: K231827(Traditional)
ATTN: José Ramón Rivero PHONE NO : 34 945 297030
Leonardo Da Vinci 14 SE DECISION MADE: 15-SEP-23
Miñano ES 01510 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Pounce™ Sheath
Surmodics, Inc. 510(k) NO: K231828(Traditional)
ATTN: Peter Bather PHONE NO : 952 5007548
7905 Golden Triangle Dr. Ste. 190 SE DECISION MADE: 07-SEP-23
Eden Prairie MN 55344 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Access Myoglobin
Beckman Coulter, Inc 510(k) NO: K231832(Traditional)
ATTN: Kate Oelberg PHONE NO : 612 4317315
1000 Lake Hazeltine Drive SE DECISION MADE: 18-SEP-23
Chaska MN 55318 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Brainomix 360 Triage LVO
Brainomix Limited 510(k) NO: K231837(Traditional)
ATTN: Thais Sala PHONE NO : 0044 737 5967695
First Floor, Seacourt Tower West WSE DECISION MADE: 28-SEP-23
Oxford GB OX2 0JJ 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 1788 4K Camera System with Advanced Imaging Modality; L12 LED Light Source with AIM
Stryker 510(k) NO: K231854(Traditional)
ATTN: April Malmborg PHONE NO : 408 5742473
5900 Optical Court SE DECISION MADE: 20-SEP-23
San Jose CA 95138 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRIOCLEAR System
Modern Dental Laboratory (DG) Co.,510(k) NO: K231884(Special)
ATTN: Robin Liu PHONE NO : 07 69 22899211__
Room 102&1102 & Floor 4-10, Block SE DECISION MADE: 01-SEP-23
Dongguan CN 523000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD Texium™ Needle-Free Syringe
Carefusion 510(k) NO: K231888(Traditional)
ATTN: Breanna Casados PHONE NO : 801 8577561
10020 Pacific Mesa Blvd SE DECISION MADE: 25-SEP-23
San Diego CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Virtue Male Sling System with Alexis Wound Retractor Convenience Kit
Coloplast 510(k) NO: K231891(Traditional)
ATTN: Jennifer Mrkvicka PHONE NO : 612___ 7075062
1601 West River Road North SE DECISION MADE: 25-SEP-23
Minneapolis MN 55411 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Definium Pace Select
GE Hualun Medical Systems Co. Ltd.510(k) NO: K231892(Traditional)
ATTN: Miny Liu PHONE NO : 86 173 10313927
No. 1 Yong Chang North Road, BeijiSE DECISION MADE: 12-SEP-23
Beijing CN 100176 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LED Spectrum therapy instrument
Shenzhenshi Sincoheren S&T Develop510(k) NO: K231894(Traditional)
ATTN: Zhongzhou Li PHONE NO : 86 158 10585973
Floor 4,No.2 Plant,No.14 ZhongxingSE DECISION MADE: 20-SEP-23
Shenzhen CN 518118 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Hakon, Hakon Smart
Medical San Indústria de Equipamen510(k) NO: K231901(Traditional)
ATTN: Francis Laion de Padua PHONE NO : 55 51____ 37202762
Rua Alberto Muller, 1100 Block 20 SE DECISION MADE: 28-SEP-23
Lajeado BR 95913-528 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EFAI RTSUITE CT HCAP-Segmentation System
Ever Fortune.AI Co., Ltd. 510(k) NO: K231928(Special)
ATTN: Joseph Chang PHONE NO : 86 642 3226363
8 F., No. 573, Sec. 2, Taiwan BlvdSE DECISION MADE: 25-SEP-23
Taichung City TW 403020 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SafeBreak® Vascular
Lineus Medical 510(k) NO: K231957(Traditional)
ATTN: Vance Clement PHONE NO :
179 North Church Ave, Suite 202 SE DECISION MADE: 29-SEP-23
Fayetteville AZ 72701 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DEKA PHYSIQ 360
El.En. S.p.A 510(k) NO: K231971(Traditional)
ATTN: Paolo Peruzzi PHONE NO : 39 055 8826807
Via Baldanzese 17 SE DECISION MADE: 26-SEP-23
Calenzano IT 50141 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PolyIsoprene Powder Free Black Colour Radiation Attenuating Surgical Glove
Ineo Tech Sdn Bhd 510(k) NO: K231973(Traditional)
ATTN: Pierre Hoerner PHONE NO : 33 670 219545
PT5825, Jalan Cassia Selatan 3/11 SE DECISION MADE: 29-SEP-23
Bandar Kassia MY 14110 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PEACH 2, PEACH 2 Duo, PEACH 2 go
Foreo Inc. 510(k) NO: K231977(Traditional)
ATTN: Evan Feldstein PHONE NO : 419 3761923
1525 E Pama Lane SE DECISION MADE: 25-SEP-23
Las Vegas NV 89119 510(k) STATEMENT
DEVICE: Steriking® LT-Blueline Pouches with Tyvek®
Wipak OY 510(k) NO: K231996(Special)
ATTN: Hanna Marttila PHONE NO : 35 804 01240290__
Wipaktie 2 SE DECISION MADE: 07-SEP-23
Nastola FI FI-15560 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Steriking® LT-Blueline Pouches with Tyvek®
Wipak OY 510(k) NO: K231999(Special)
ATTN: Hanna Marttila PHONE NO : 358 040 1240290
Wipaktie 2 SE DECISION MADE: 07-SEP-23
Nastola FI FI-15560 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vantage® Total Ankle System
Exactech Inc. 510(k) NO: K232002(Traditional)
ATTN: Liz Howell PHONE NO : 352 3771140
2320 NW 66th Court SE DECISION MADE: 11-SEP-23
Gainesville FL 32653 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CONDUIT™ ATP Inserters
Enztec Limited 510(k) NO: K232014(Special)
ATTN: James Sheat PHONE NO : 64 348 0203
3/17 Print Place Middleton SE DECISION MADE: 01-SEP-23
Christchurch NZ 8024 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Smart Fit TorsoCardiac 1.5T and Smart Fit Shoulder 1.5T
Philips Healthcare (Suzhou) Co., L510(k) NO: K232021(Traditional)
ATTN: Li Sherry PHONE NO : 86 178 49535031
No. 258, Zhongyuan Road Suzhou IndSE DECISION MADE: 01-SEP-23
Suzhou CN 215024 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HyperLight Portable X-ray Unit
Changzhou Sifary Medical Technolog510(k) NO: K232068(Traditional)
ATTN: Tao Huan PHONE NO : 86 186 02591004
No.99 Qingyang Road, Xuejia CountySE DECISION MADE: 01-SEP-23
Changzhou CN 213000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IdentiTi ALIF Interbody Systems
Alphatec Spine, Inc. 510(k) NO: K232097(Traditional)
ATTN: Andrew Zhang PHONE NO : 1 760 4946806
1950 Camino Vida Roble SE DECISION MADE: 25-SEP-23
Carlsbad CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ClearPoint Array System (Version 1.2)
ClearPoint Neuro, Inc. 510(k) NO: K232102(Special)
ATTN: Brennan Sullivan PHONE NO : 617 6781028
5 Musick SE DECISION MADE: 15-SEP-23
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Power wheelchair (Model:BC-EA8000)
Ningbo Baichen Medical Devices Co.510(k) NO: K232121(Traditional)
ATTN: Wu Xiao Long PHONE NO : 86 1515 8388666___
Room 903, 666 Taikang Middle Road,SE DECISION MADE: 15-SEP-23
Ningbo CN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IPL Hair Removal, Model: W-1095, W-1098
Shenzhen Wochuan Electronic Co., L510(k) NO: K232124(Traditional)
ATTN: Rebecca Jiang PHONE NO : 86 138 23355685
6th Floor Building No.357 3rd AreaSE DECISION MADE: 14-SEP-23
Shenzhen CN 518103 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Anovo Pedestal
Momentis Surgical Ltd. 510(k) NO: K232146(Traditional)
ATTN: Maya Leib Shlomo PHONE NO : 97 250 8852822
3 Yahadut Canada St. SE DECISION MADE: 14-SEP-23
Or Yehuda IL 6037503 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate Fixation
MiRus, LLC 510(k) NO: K232154(Traditional)
ATTN: Jordan Bauman PHONE NO : 404 3458235
1755 West Oak Parkway, Suite 100 SE DECISION MADE: 11-SEP-23
Marietta GA 30062 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GenX-CR
Genoray Co., Ltd. 510(k) NO: K232158(Traditional)
ATTN: Inyoung Kim PHONE NO : 82 31 51785770
#512, 560, Dunchon-daero, Jungwon-SE DECISION MADE: 13-SEP-23
Seongnam-si KR 13230 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QEVO System
Carl Zeiss Meditec AG 510(k) NO: K232159(Special)
ATTN: Eva Jankovics PHONE NO : 49____ 7364 2080406
Rudolf-Eber-Strasse 11 SE DECISION MADE: 21-SEP-23
Oberkochen DE 73447 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PreXion3D Expedition
PreXion Corporation 510(k) NO: K232166(Traditional)
ATTN: Kenji Tanaka PHONE NO : 81 3 52977553
1-14-1, Kandasuda-cho SE DECISION MADE: 08-SEP-23
Chiyoda-ku JP 101-0041 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VySpan™ PCT System
Vy Spine, LLC 510(k) NO: K232167(Special)
ATTN: Jordan Hendrickson PHONE NO : 866 4897746
2236 Capital Circle NE, Suite 103-SE DECISION MADE: 27-SEP-23
Tallahassee FL 32308 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BTL-785BNF Handpiece
BTL Industries Inc. 510(k) NO: K232172(Traditional)
ATTN: David Chmel PHONE NO : 1 866 2851656
362 Elm Street SE DECISION MADE: 18-SEP-23
Marlborough MA 01752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GXR-ES/ECS Diagnostic X-Ray System, (Models GXR-ES series, GXR-ECS series)
DRGEM Corporation 510(k) NO: K232178(Traditional)
ATTN: Park Sunghee PHONE NO : 82 10 32516768
7F/13F, E-B/D Gwangmyeong Techno-PSE DECISION MADE: 19-SEP-23
Gwang-Myeong-si KR 14322 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IPL Hair Removal Device, Model(s): T1, T2, T3, T7, T10
Shenzhen Koli Technology Co.,Ltd 510(k) NO: K232183(Traditional)
ATTN: Qizhen Fu PHONE NO : 86 158 18667227
Floor 4, No. 145-1 Furui Road, XinSE DECISION MADE: 22-SEP-23
Shenzhen CN 518103 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OrionXR
Hoth Intelligence Inc. 510(k) NO: K232189(Traditional)
ATTN: Jonathan Cohen PHONE NO : 516 6607971
1700 Market Street Unit 1005 SE DECISION MADE: 14-SEP-23
Philadelphia PA 19103 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Venus Versa PRO System
Venus Concept Inc. 510(k) NO: K232192(Special)
ATTN: William H. McGrail PHONE NO : 978 8080420
1800 Bering Drive SE DECISION MADE: 11-SEP-23
San Jose CA 95112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Electrically Power Wheelchairs (Models:YLB-W-0812-A01, YLB-W-0812-A02, YLB-W-0812-A03)
Yurob Rehabilitation Medical Co.,L510(k) NO: K232193(Traditional)
ATTN: Pan Daoping PHONE NO : 86 1391 8374973
No.93 Dianxing Road, Dianshanhu ToSE DECISION MADE: 22-SEP-23
Kunshan CN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Reclining wheelchair (YJ-011S 16”D, YJ-011S 16”DF, YJ-011S 18”D, YJ-011S 18”DF, YJ-011S 20”D, YJ-011S 20”DF)
Zhenjiang Assure Medical Equipment510(k) NO: K232198(Traditional)
ATTN: Ying Mei PHONE NO : 0086 13 85294120
NO.297, Chuqiao Road SE DECISION MADE: 15-SEP-23
Zhenjiang CN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Bariatric Heavy Duty Wheelchair (YJ-010B 20’’DS; YJ-010B 20’’DE; YJ-010B 20’’DFS; YJ-010B 20’’DFE;YJ-010B 20’’ADS; YJ-010B 20’’ADE; YJ-010B 20’’ADFS; YJ-010B 20’’ADFE; YJ-010B 22’’DS; YJ-010B 22’’DE; YJ-010B 22’’DFS;YJ-010B 22’’DFE; YJ-010B 22’’ADS;YJ-010B 22’’ADE; YJ-010B 22’’ADFS; YJ-010B 22’’ADFE; YJ-010B 24’’DS; YJ-010B 24’’DE; YJ-010B 24’’DFS; YJ-010B 24’’DFE; YJ-010B 24’’ADS; YJ-010B 24’’ADE; YJ-010B 22’’ADFS; YJ-010B 24’’ADFE)
Zhenjiang Assure Medical Equipment510(k) NO: K232199(Traditional)
ATTN: Ying Mei PHONE NO : 0086 1385 294120
No.297, Chuqiao Road, Zhenjiang CiSE DECISION MADE: 15-SEP-23
Zhenjiang CN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: iLet® Dosing Decision Software
Beta Bionics, Inc. 510(k) NO: K232224(Traditional)
ATTN: Liz Cooper PHONE NO : 732 2755848
300 Baker Avenue, Suite 301 SE DECISION MADE: 22-SEP-23
Concord MA 01742 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Invisalign System with Mandibular Advancement Featuring Occlusal Blocks
Align Technology, Inc. 510(k) NO: K232233(Traditional)
ATTN: John Ray PHONE NO : 425 9858061
2820 Orchard Parkway SE DECISION MADE: 26-SEP-23
San Jose CA 95134 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EZSensor XHD
Qpix Solutions Inc. 510(k) NO: K232255(Traditional)
ATTN: Seungman Yun PHONE NO : 1 919 9086917
1001 Aviation Parkway, Ste 200 SE DECISION MADE: 27-SEP-23
Morrisville NC 27560 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Thinline Sheath Introducer
Inneuroco Inc. 510(k) NO: K232260(Traditional)
ATTN: Marc Litzenberg PHONE NO : 954 4725988
19700 Stirling Road, Suite 1 SE DECISION MADE: 27-SEP-23
Pembroke Pines FL 33332 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IPL hair removal device
Lumenessa Corp 510(k) NO: K232274(Traditional)
ATTN: Peter Kim PHONE NO : 1 408 5623072121
10606 Shoemaker Ave #A SE DECISION MADE: 28-SEP-23
Santa Fe Springs CA 90670 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Invictus® Spinal Fixation System
Alphatec Spine, Inc. 510(k) NO: K232275(Traditional)
ATTN: Cynthia Dorne PHONE NO : 760 4946740
1950 Camino Vida Roble SE DECISION MADE: 27-SEP-23
Carlsbad CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CeraPutty
Meta Biomed Co., Ltd. 510(k) NO: K232299(Traditional)
ATTN: Suk Song Oh PHONE NO : 82 43 2308841
270, Osongsaengmyeong 1-ro, Osong-SE DECISION MADE: 29-SEP-23
Cheongju-si KR 28161 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Hood (DH-106STL, DH-116STL, DH-126STL, DH-096ST)
Fujifilm Healthcare Americas Corpo510(k) NO: K232314(Special)
ATTN: Chaitrali Kulkarni PHONE NO : 704 5174886
81 Hartwell Avenue Suite 300 SE DECISION MADE: 01-SEP-23
Lexington MA 02421 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Catalyst Bone Void Filler
OssDsign AB 510(k) NO: K232315(Traditional)
ATTN: Jonas Aberg PHONE NO : 1 401 7755465
Rapsgatan 23 A SE DECISION MADE: 15-SEP-23
Uppsala IE SE 754 50 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DEKA SIMON
El.En. S.p.A. 510(k) NO: K232334(Special)
ATTN: Paolo Peruzzi PHONE NO : 39 055 8826807
Via Baldanzese 17 SE DECISION MADE: 01-SEP-23
Calenzano IT 50141 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ES Series V2
E-Scopics 510(k) NO: K232336(Special)
ATTN: Claude Cohen Bacrie PHONE NO : 00 336 84323275
931 Chemin de la Bosque d'AntonellSE DECISION MADE: 26-SEP-23
Aix en Provence FR 13090 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Arthrex 2.4mm Knotless Hip SutureTak® Suture Anchor
Arthrex Inc. 510(k) NO: K232340(Special)
ATTN: Alex Underberg PHONE NO : 1 901 6064046
1370 Creekside Boulevard SE DECISION MADE: 01-SEP-23
Naples FL 34108 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Promaxo MRI System II
Promaxo, Inc. 510(k) NO: K232361(Special)
ATTN: Veronica Sanz PHONE NO : 510 4625456
70 Washington St, Suite 407 SE DECISION MADE: 05-SEP-23
Oakland CA 94607 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ILUMIEN™ OPTIS™ System, OPTIS™ Integrated System, OPTIS™ Mobile System, with AptiVue™ Imaging Software version E.6
Abbott Medical 510(k) NO: K232386(Special)
ATTN: Derek Pike PHONE NO : 978 4675880
4 Robbins Road SE DECISION MADE: 08-SEP-23
Westford MA 01886 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Carescape SpO2 - Masimo; Masimo rainbow SET IntelliVue
Masimo Corporation 510(k) NO: K232389(Special)
ATTN: Kertana Shankar PHONE NO : 949 3900140
52 Discovery SE DECISION MADE: 07-SEP-23
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VariSeed (v10)
Varian Medical Systems 510(k) NO: K232400(Special)
ATTN: Lynn Allman PHONE NO : 650 4246500
3100 Hansen Way M/S E-110 SE DECISION MADE: 08-SEP-23
Palo Alto CA 94304 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Fusion Robotic Navigation System
Alphatec Spine, Inc. 510(k) NO: K232413(Special)
ATTN: Sarah Braun PHONE NO : 423 8384454
168 Centennial Parkway, Unit 170 SE DECISION MADE: 08-SEP-23
Louisville CO 80027 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Klassic® Tibial Insert, PS-Post, Klassic All Poly Tibia, PS-Post
Total Joint Othopedics, Inc. 510(k) NO: K232414(Special)
ATTN: Chris Weaber PHONE NO : 801 4866070
1567 E. Stratford Avenue SE DECISION MADE: 08-SEP-23
Salt Lake City UT 84106 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate Sacrificing (CS) Inserts
Conformis Inc 510(k) NO: K232426(Special)
ATTN: Mary Kruitwagen PHONE NO : 781 3439038
600 Technology Park Drive Fourth FSE DECISION MADE: 08-SEP-23
Billerica MA 01821 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Single-Loop Snare Retrieval Kit, Triple-Loop Snare Retrieval Kit
Argon Medical Devices, Inc. 510(k) NO: K232443(Special)
ATTN: Ana Jimenez-Hughes PHONE NO : 903 6764276
1445 Flat Creek Road SE DECISION MADE: 07-SEP-23
Athens TX 75751 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Q-FIX ULTRA All-Suture Anchor
Smith & Nephew 510(k) NO: K232457(Special)
ATTN: Catherine Phelan PHONE NO : 508 4464542
150 Minuteman Road SE DECISION MADE: 08-SEP-23
Andover MA 01810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Velacur
Sonic Incytes 510(k) NO: K232459(Special)
ATTN: Barry Allen PHONE NO :
#309-1788 West 5th Ave SE DECISION MADE: 12-SEP-23
Vancouver CA V6J 1P2 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ThermPix Thermovisual Camera
USA Therm, Inc. 510(k) NO: K232462(Special)
ATTN: Eric Heil PHONE NO : 1 844 9984376
3100 Ray Ferrero Jr. Blvd, 5th FloSE DECISION MADE: 14-SEP-23
Fort Lauderdale FL 33314 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CleanCart A, CleanCart C, AK 98 Hemodialysis Machine
Baxter Healthcare Corporation 510(k) NO: K232467(Special)
ATTN: Kristen Bozzelli PHONE NO : 224 9485585
25212 W. Illinios Route 120 SE DECISION MADE: 14-SEP-23
Round Lake IL 60073 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAGNETOM Viato.Mobile
Siemens Medical Solutions USA, Inc510(k) NO: K232482(Special)
ATTN: Alina Goodman PHONE NO : 1 224 5261404
40 Liberty Boulevard SE DECISION MADE: 06-SEP-23
Malvern PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AMSCO 600 Steam Sterilizer
Steris 510(k) NO: K232485(Special)
ATTN: Anthony Piotrkowski PHONE NO : 440 3927437
5960 Heisley Rd SE DECISION MADE: 13-SEP-23
Mentor OH 44060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Provecta 3D Prime and Provecta 3D Prime Ceph
Durr Dental SE 510(k) NO: K232487(Special)
ATTN: Oliver Lange PHONE NO : 49 71 42705190
Höpfigheimer Str. 17 SE DECISION MADE: 14-SEP-23
Bietigheim-Bissingen DE 74321 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Barrier EasyWarm Active Self-Warming Blanket
Molnlycke Health Care US, LLC 510(k) NO: K232508(Special)
ATTN: Megan Bevill PHONE NO : 770 5479196
5445 Triangle Parkway, Suite 400 SE DECISION MADE: 15-SEP-23
Peachtree Corners GA 30092 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: X-Twist Biocomposite Suture Anchor
Parcus Medical 510(k) NO: K232513(Special)
ATTN: Calen Souther PHONE NO : 781 4579541
6455 Parkland Drive SE DECISION MADE: 18-SEP-23
Sarasota FL 34243 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5
Canon Medical Systems Corporation 510(k) NO: K232526(Special)
ATTN: Paul Biggins PHONE NO : 951 6697808
1385 Shimoshigami SE DECISION MADE: 12-SEP-23
Otawara-shi JP 324-8550 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Stable-L Standalone Lumbar Interbody System, Stable-C Interbody System
Nexus Spine, LLC 510(k) NO: K232530(Special)
ATTN: Jared Crocker PHONE NO : 801 7028592
2825 East Cottonwood Parkway SuiteSE DECISION MADE: 18-SEP-23
Salt Lake City UT 84121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Apollo ESG NXT System, Apollo REVISE NXT System
Apollo Endosurgery Inc. 510(k) NO: K232544(Special)
ATTN: James Shene PHONE NO : 512 8523793
1120 South Capital of Texas Hwy., SE DECISION MADE: 18-SEP-23
Austin TX 78746 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DePuy 3D Additive TriFlange Acetabular Cup and DePuy TriFlange II Acetabular Cup System
Depuy Ireland UC 510(k) NO: K232556(Special)
ATTN: Susan Mullane PHONE NO : 35 32 14914000
Loughbeg Ringaskiddy SE DECISION MADE: 20-SEP-23
Cork IE 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UroLift 2 ATC Advanced Tissue Control System
NeoTract, Inc. 510(k) NO: K232558(Special)
ATTN: Kelsey Krische PHONE NO : 1 303 7756821
4155 Hopyard Rd. SE DECISION MADE: 22-SEP-23
Pleasanton CA 94588 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CAREMIBRAIN
General Equipment for Medical Imag510(k) NO: K232569(Third Party - Traditional)
ATTN: Maria Climent PHONE NO : 34 96 3722472___
(Oncovision Gem-Imaging S.A.) CallSE DECISION MADE: 21-SEP-23
Valencia ES 46022 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: CATHTONG™ II PICC Catheter
L&Z US, Inc. 510(k) NO: K232571(Special)
ATTN: James Li PHONE NO : 201 6608868 3
49 Walnut Street Unit 1 SE DECISION MADE: 22-SEP-23
Norwood NJ 07648 510(k) STATEMENT
DEVICE: Ambu® aScope™ 5 Broncho 4.2/2.2 Sampler Set
Ambu A/S 510(k) NO: K232582(Special)
ATTN: Eva Lind Rasmussen PHONE NO : 45 72 252080
Baltorpbakken 13 SE DECISION MADE: 20-SEP-23
Ballerup DK 2750 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Catalyst R1 Reverse Shoulder System
Catalyst OrthoScience, Inc. 510(k) NO: K232583(Special)
ATTN: Dale Davison PHONE NO : 239 3259976 102
14710 Tamiami Trail N. SE DECISION MADE: 20-SEP-23
Naples FL 34110 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CITRELOCK® DUO
Acuitive Technologies, Inc. 510(k) NO: K232592(Special)
ATTN: Matthew Poggie PHONE NO : 201 6612678
50 Commerce Drive SE DECISION MADE: 20-SEP-23
Allendale NJ 07401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CATHTONG™ II PICC Catheter
L&Z US, Inc. 510(k) NO: K232594(Special)
ATTN: James Li PHONE NO : 201 6608868 3
49 Walnut Street Unit 1 SE DECISION MADE: 22-SEP-23
Norwood NJ 07648 510(k) STATEMENT
DEVICE: EndoGI S-Path Biliary Stent System
EndoGI Medical, Ltd. 510(k) NO: K232596(Special)
ATTN: Omri Naveh PHONE NO : 97 252 4625474
13 Wadi El Hadj SE DECISION MADE: 27-SEP-23
Nazareth IL 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue® MAX™ + Invue Inset Anterior Cervical Plate System, and FacetFuse® Screw Fixation System
LESspine Innovations 510(k) NO: K232605(Special)
ATTN: Vito Lore PHONE NO : 978 2323990
350 Main St SE DECISION MADE: 28-SEP-23
Malden MA 02148 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Micro Ace™ Advanced Micro Access System
Merit Medical Systems, Inc. 510(k) NO: K232609(Special)
ATTN: Garry Courtney PHONE NO : 302 2704789
1600 West Merit Parkway SE DECISION MADE: 27-SEP-23
South Jordan UT 84095 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Volta AF-Xplorer
Volta Medical 510(k) NO: K232616(Special)
ATTN: Paola Milpied PHONE NO : 337 6802 5499
65 Avenue Jules Cantini SE DECISION MADE: 27-SEP-23
Marseille FR 13006 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACUSON Maple Diagnostic Ultrasound System, ACUSON Maple Select Diagnostic Ultrasound System
Siemens Medical Solutions, USA, In510(k) NO: K232617(Third Party - Traditional)
ATTN: Shilpa Rapaka PHONE NO : 512 9131053___
22010 South East 51st Street SE DECISION MADE: 26-SEP-23
Issaquah WA 98029 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: Microcatheter
Surmodics. Inc. 510(k) NO: K232647(Special)
ATTN: Jodie Christe PHONE NO : 1 952 5007065
9924 West 74th Street SE DECISION MADE: 29-SEP-23
Eden Prairie MN 55344 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KHEIRON® Spinal Fixation System, including patient specific K-ROD
S.M.A.I.O 510(k) NO: K232650(Special)
ATTN: Jean-Charles Roussouly PHONE NO : 33 670 165171
2 place Berthe Morisot SE DECISION MADE: 29-SEP-23
Saint Priest FR 69800 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BLAZER™ Dx-20 Bidirectional Steerable Diagnostic Catheter
Boston Scientific Corporation 510(k) NO: K232651(Special)
ATTN: Laura Wotta PHONE NO : 651 5812151
4100 Hamline Ave North SE DECISION MADE: 29-SEP-23
St. Paul MN 55112-5798 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: InnerView LC
Perimetrics, Inc 510(k) NO: K232657(Third Party - Traditional)
ATTN: Alicia Mszyca PHONE NO : 714 3259887
360 San Miguel, Suite 204 SE DECISION MADE: 01-SEP-23
Newport Beach CA 92600 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: Cove Strip, OsteoCove Strip
SeaSpine Orthopedics Corporation 510(k) NO: K232668(Special)
ATTN: Cindy Toyama PHONE NO : 949 8557175
5770 Armada Drive SE DECISION MADE: 27-SEP-23
Carlsbad CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TBI
Abbott Laboratories 510(k) NO: K232669(Special)
ATTN: Lisa Kelly PHONE NO : 224 6688849
100 Abbott Park Road Dept.09AA, BuSE DECISION MADE: 29-SEP-23
Abbott Park IL 60064 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CorVista® System
CorVista Health, Inc. 510(k) NO: K232686(Traditional)
ATTN: Gabrielle Zaeska PHONE NO : 612 2675004
7144 13th Place NW, Suite 2200 SE DECISION MADE: 08-SEP-23
Washington DC 20012 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Amulet™ Steerable Delivery Sheath
Abbott Medical 510(k) NO: K232690(Special)
ATTN: Dan Gapp PHONE NO : 612 2831408
177 County Road B East SE DECISION MADE: 29-SEP-23
St. Paul MN 55117 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Polibond
Zirkonzahn Srl 510(k) NO: K232691(Third Party - Traditional)
ATTN: Sorana Siclovan PHONE NO : 39 0474 066660
An der Ahr 7 SE DECISION MADE: 05-SEP-23
Gais IT 39030 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: Low Ejection Fraction AI-ECG Algorithm
Anumana, Inc. 510(k) NO: K232699(Traditional)
ATTN: Suzanne Goodman PHONE NO : 1 919 6086082
One Main Street, Suite 400 East ArSE DECISION MADE: 28-SEP-23
Cambridge MA 02142 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Guardenia (GAR-1)
Advanced Surgical Concepts 510(k) NO: K232701(Special)
ATTN: Edward Hyland PHONE NO : 35 312 864777
Unit 4, Sunnybank Center Upper DarSE DECISION MADE: 29-SEP-23
Bray IE A98 E339 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LightForce Orthodontic System
LightForce Orthodontics 510(k) NO: K232827(Third Party - Traditional)
ATTN: Jeffrey Roberts PHONE NO : 800 4810185
44 Third Ave SE DECISION MADE: 14-SEP-23
Burlington MA 01803 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: DX. Bond V Dental Bonding Adhesive
Sino-Dentex Co., Ltd. 510(k) NO: K232978(Third Party - Traditional)
ATTN: Pengtao Yan PHONE NO : 086 189 43173317
1000 Westgate Drive Suite #510k SE DECISION MADE: 22-SEP-23
Saint Paul MN 55114 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: BeautiLink SA
Shofu Dental Corporation 510(k) NO: K233161(Third Party - Traditional)
ATTN: Mauro Malzyner PHONE NO : 760 7363277 202
1225 Stone Drive SE DECISION MADE: 28-SEP-23
San Marcos CA 92078 510(k) STATEMENT
THIRD PARTY REVIEW
DEVICE: 3M™ Clarity™Aligners with Quick Attachments
3M Company, Unitek Orthodontic Pro510(k) NO: K233257(Third Party - Traditional)
ATTN: Hillary Peetsch PHONE NO : 612 7109847___
2510 Conway Avenue SE DECISION MADE: 29-SEP-23
St. Paul MN 55144 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
TOTAL 510(k)s THIS PERIOD 308
TOTAL WITH SUMMARIES 294
TOTAL WITH STATEMENTS 14
