510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD August 2020
DEVICE: StimaWELL 120MTRS
Pierenkemper GmbH 510(k) NO: K181645(Traditional)
ATTN: Thorsten Reichel PHONE NO : 49 06443 8333175
Am Geiersberg 6 SE DECISION MADE: 13-AUG-20
Ehringshausen DE 35630 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NADIA SI Fusion System
Ilion Medical Inc 510(k) NO: K190580(Traditional)
ATTN: Tania Fuentes-Davitt PHONE NO : 612 3322324
825 Nicollet Mall Suite 715 SE DECISION MADE: 05-AUG-20
Minneapolis MN 55402 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: "ORION" Spinal System
Orion Biotech Inc. 510(k) NO: K190600(Abbreviated)
ATTN: Yuki Chen PHONE NO : 886 2 25503366 209
5F-1, No.88, Sec.2, Chong-qing N. SE DECISION MADE: 18-AUG-20
Taipei TW 103 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Konix Anti-Fog Solution
Turkuaz Saglik Hizmetleri Medikal 510(k) NO: K190864(Traditional)
ATTN: Nurham Irmak PHONE NO : 90 212 4286848
San. ve Tic. LTD No. 34 BeylikduzuSE DECISION MADE: 27-AUG-20
Istanbul TR 34524 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Orthodontic Fixation Screw [Smart Anchor Miniscrew]
GNI Co., LTD 510(k) NO: K191041(Traditional)
ATTN: Duk Soo Kim PHONE NO : 82 505 6008880
5F 501, 63-12 DongtancheomdansaneoSE DECISION MADE: 28-AUG-20
Hwaseong KR 18469 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Pointe Scientific Creatinine Kinase (CK) Reagent Set
MedTest Dx 510(k) NO: K191296(Traditional)
ATTN: William Cripps PHONE NO : 734 4878300 120
5449 Research Drive SE DECISION MADE: 11-AUG-20
Canton MI 48188 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BB Base 3D printing resin for denture base
Enlighten Materials Co., Ltd 510(k) NO: K191591(Traditional)
ATTN: Jiun Ming Su PHONE NO : 886 886 956973958
8F., NO.138, Sec.2, Jinshan S. Rd.SE DECISION MADE: 18-AUG-20
Taipei TW 10642 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TK Intravascular Administration Set
Anhui Tiankang Medical Technology 510(k) NO: K191640(Traditional)
ATTN: Bai Baodong PHONE NO : 86 550 7309187
No.228 Weiyi Road, Economic DeveloSE DECISION MADE: 26-AUG-20
Tianchang CN 239300 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TK Safety Needle
Anhui Tiankang Medical Technology 510(k) NO: K191644(Traditional)
ATTN: Bai Baodong PHONE NO : 86 550 7309187
No.228 Weiyi Road, Economic DeveloSE DECISION MADE: 06-AUG-20
Tianchang CN 239300 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CureOs TCP
Linacol Muh Dan Kim Cev Tek Med It510(k) NO: K191670(Traditional)
ATTN: Mehmet Ali Cengiz PHONE NO : 90 312 2992563
Universiteler Mah. 1596. Cd. SafirSE DECISION MADE: 04-AUG-20
Ankara TR 06800 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Origin Stem, Evolve Stem, Aria Hip Stem, Remedy Stem, CoCr Femoral Head
Signature Orthopaedics Pty Ltd. 510(k) NO: K191708(Traditional)
ATTN: Declan Brazil PHONE NO : 61 2 94285181
7 Sirius Road SE DECISION MADE: 14-AUG-20
Lane Cove AU 2066 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FitRelief TENS&EMS Wireless Device
Heat In A Click LLC. 510(k) NO: K191938(Traditional)
ATTN: Guy Levi PHONE NO : 954 5189777
1975 Tigertail Blvd SE DECISION MADE: 28-AUG-20
Dania FL 33004 510(k) STATEMENT
DEVICE: Enhanced External Counter Pulsation Device Plus Omay-A
Omay(Guangzhou)Med Technologies Co510(k) NO: K191955(Traditional)
ATTN: Peixian Su PHONE NO : 86 020 37092519
Room 302,3F, No. 600-1, Guangshan SE DECISION MADE: 05-AUG-20
Guangzhou CN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nucleoss T6 Dental Implant System
Sanlilar Tibbi Cihazlar Medikal Ki510(k) NO: K192062(Traditional)
ATTN: Ezgi Ozbudak PHONE NO : 90 232 7990304
10018 Sok. No 7. ITOB Sanayi BölgeSE DECISION MADE: 27-AUG-20
Izmir TR 35477 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ProSeal™ Closed System drug Transfer Device (CSTD)
Epic Medical Pte. Ltd. 510(k) NO: K192075(Traditional)
ATTN: Freddie Lee PHONE NO : 65 9635 2618
10 Jalan Besar, #06-04, Sim Lim ToSE DECISION MADE: 07-AUG-20
Singapore SG 208787 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: invisa-RED ELITE
IR Technology LLC 510(k) NO: K192275(Traditional)
ATTN: Thomas A. Namynanik PHONE NO : 888 2217119
2707 Hampton TRL SE DECISION MADE: 19-AUG-20
Woodstock GA 30189 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TidalPort-AP Implantable Apheresis Vascular Access Port
Norfolk Medical Products, Inc. 510(k) NO: K192291(Traditional)
ATTN: Natan Pheil PHONE NO : 847 6747075
7350 N. Ridgeway Avenue SE DECISION MADE: 20-AUG-20
Skokie IL 60076 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ST AIA-PACK BNP
Fujirebio Diagnostics, Inc. 510(k) NO: K192380(Traditional)
ATTN: Stacey Dolan PHONE NO : 610 2403843
201 Great Valley Parkway SE DECISION MADE: 24-AUG-20
Malvern PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Injection Pen Needle
Gangan Medical Technology Jiangsu 510(k) NO: K192464(Traditional)
ATTN: Wu Shuhui PHONE NO : 86 010569 65029
1st-4th Flr, Building G130, Fifth SE DECISION MADE: 25-AUG-20
Taizhou City CN 225300 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 1ml Luer Slip or Luer Lock Syringe, Syringe with permanently attached needle, Safety Syringe with permanently attached needle
Jiangsu Caina Medical Co., Ltd. 510(k) NO: K192551(Traditional)
ATTN: Xinyan Ruan PHONE NO : 86 139 61664075
No.23, Huanxi Road, Zhutang Town SE DECISION MADE: 10-AUG-20
Jiangyin CN 214415 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cytrans Granules
GC America, Inc. 510(k) NO: K192597(Abbreviated)
ATTN: Mark Heiss PHONE NO : 708 9263090
3737 W. 127th St. SE DECISION MADE: 17-AUG-20
Alsip IL 60803 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cuffix
Biovo Technologies Ltd. 510(k) NO: K192611(Traditional)
ATTN: Barbara Sokoletsky PHONE NO : 972 72 2151115
23 HaMelacha St SE DECISION MADE: 13-AUG-20
ROsh HaAyin IL 4809173 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SNA-001 Silver Photoparticle Topical Gel
Sienna Biopharmaceuticals, Inc. 510(k) NO: K192620(Traditional)
ATTN: Paul Lizzul PHONE NO : 818 6292256
30699 Russell Ranch Road, Suite 14SE DECISION MADE: 12-AUG-20
Westlake Village CA 91362 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sterile High-pressure Angiographic Syringes for Single-use
Shenzhen Boon Medical Supply Co., 510(k) NO: K192657(Traditional)
ATTN: Mingan Mu PHONE NO : 86 755 28638515
No 6 Shenkeng Road, Shenkeng IndusSE DECISION MADE: 07-AUG-20
Shenzhen CN 518173 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Hemostatic Xerogel Sponge
Solaplus Biotech Co., Ltd. 510(k) NO: K192671(Traditional)
ATTN: Xiangui Shen PHONE NO : 86 057788 597999
No. 75 Feng Fang Road, Ouhai EconoSE DECISION MADE: 28-AUG-20
Wenzhou CN 325014 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Orthocem, Ortho Bite
Dentscare Ltda 510(k) NO: K192682(Traditional)
ATTN: Roberta Uyara PHONE NO : 55 47 34416131
Av. Edgar Nelson Meister, 474 SE DECISION MADE: 14-AUG-20
Joinville BR 89219-501 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Attain Select II + SureValve delivery catheter system, Attain Command + SureValve Left Heart Delivery System, Attain Comman + SureValve Guide Catheters for Left Heart Delivery, C315 Delivery Catheter
Medtronic Inc 510(k) NO: K192712(Traditional)
ATTN: Sharon Fahy PHONE NO : 353 91 708161
Parkmore Business Park West SE DECISION MADE: 03-AUG-20
Galway IE 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Coloring Liquid
Aidite (Qinhuangdao) Technology Co510(k) NO: K192723(Traditional)
ATTN: Zhang Wei PHONE NO : 86 335 8587898
No.9 Dushan Road,Economic and TechSE DECISION MADE: 18-AUG-20
Qinhuangdao CN 066000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Dental Handpiece
Micro-NX Co., Ltd. 510(k) NO: K192809(Traditional)
ATTN: Sojeong Park PHONE NO : 82 053650 1000
22 Maeyeo-ro 1 gil, Dong gu SE DECISION MADE: 25-AUG-20
Daegu KR 41059 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sperm Freeze, Sperm Fridge
Kitazato Corporation 510(k) NO: K192845(Traditional)
ATTN: Futoshi Inoue PHONE NO : 81 545 662202
81 Nakajima SE DECISION MADE: 17-AUG-20
Fuji Shizuoka JP 416-0907 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MONDRIAN Lumbar Interbody Fusion Cage System
CTL Medical Corporation 510(k) NO: K192863(Traditional)
ATTN: Sean Suh PHONE NO : 214 5455820
4550 Excel Parkway #300 SE DECISION MADE: 26-AUG-20
Addison TX 75001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Spartan Hip Stem
Signature Orthopaedics Pty Ltd. 510(k) NO: K192883(Traditional)
ATTN: Declan Brazil PHONE NO : 61 2 94285181
7 Sirius Road SE DECISION MADE: 05-AUG-20
Lane Cove AU 2066 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AncestryDNA Factor V Leiden Genetic Health Risk Test
Ancestry Genomics, Inc. 510(k) NO: K192944(Traditional)
ATTN: Raajdeep Venkatesan PHONE NO : 415 7956110
153 Townsend Street, Suite 800 SE DECISION MADE: 13-AUG-20
San Francisco CA 94107 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AncestryDNA Saliva Collection Kit
Ancestry Genomics, Inc. 510(k) NO: K192947(Traditional)
ATTN: Raajdeep Venkatesan PHONE NO : 415 7956110
153 Townsend Street, Suite 800 SE DECISION MADE: 13-AUG-20
San Francisco CA 94107 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: APTOS Threads – Polypropylene Surgical Sutures
APTOS, LLC. 510(k) NO: K192953(Traditional)
ATTN: Nikolai Pirtskhalaichvili PHONE NO : 99532 2920371 501
20/4 V. Orbeliani Street SE DECISION MADE: 27-AUG-20
Tbilisi GE 0105 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vesco Medical Extension Feeding Set
Vesco Medical LLC 510(k) NO: K192991(Traditional)
ATTN: Chris O'Keefe PHONE NO : 614 9145991
1039 Kingsmill Pkwy SE DECISION MADE: 03-AUG-20
Columbus OH 43229 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIMI RRT System
Dialco Medical Inc. 510(k) NO: K193005(Traditional)
ATTN: Danijela Domljanovic PHONE NO : 416 6263233
135 The West Mall, Unit 2 SE DECISION MADE: 28-AUG-20
Toronto CA M9C1C2 510(k) STATEMENT
DEVICE: MagVenture TMS Therapy – for treatment of OCD, MagVenture TMS Therapy system
Tonica Elektronik A/S 510(k) NO: K193006(Traditional)
ATTN: Sanne Barsballe Jessen PHONE NO : 45 44 998444
Lucernemarken 15 SE DECISION MADE: 09-AUG-20
Farum DK 3520 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Straumann® Retentive System – Novaloc TiN Abutments
Institut Straumann AG 510(k) NO: K193046(Traditional)
ATTN: Ana C.M. Vianna PHONE NO : 41 61 9651259
Peter Merian Weg 12 SE DECISION MADE: 13-AUG-20
Basel CH GH-4002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Steripack cases and Tray Systems
Avalign Technologies, Inc. 510(k) NO: K193066(Traditional)
ATTN: Hiren Patel PHONE NO : 800 2554576
8727 Clinton Park Dive SE DECISION MADE: 06-AUG-20
Fort Wayne IN 46825 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Fountain ValveTip Infusion Catheter
Merit Medical Systems, Inc 510(k) NO: K193082(Traditional)
ATTN: Spriha Pandey PHONE NO : 801 2084187
1600 West Merit Parkway SE DECISION MADE: 07-AUG-20
South Jordan UT 84095 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MVP Aligner System
MVP Aligners, LLC 510(k) NO: K193130(Third Party - Traditional)
ATTN: Daniel Michaeli PHONE NO : 1 917 7542056
5-9 Union Square West SE DECISION MADE: 07-AUG-20
New York NY 10003 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: Lateralized Glenosphere
Medacta Inernational SA 510(k) NO: K193175(Traditional)
ATTN: Stefano Baj PHONE NO : 41 91 6966060
Strada Regina SE DECISION MADE: 11-AUG-20
Castel San Pietro CH cH-6874 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CER-S
CardioCalm 510(k) NO: K193177(Traditional)
ATTN: Fabio Badilini PHONE NO : 39 030 9650782
Corso Martiri della Liberta, nr. 4SE DECISION MADE: 26-AUG-20
Montichiari IT 25018 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BTL-785F
BTL 510(k) NO: K193201(Traditional)
ATTN: David Chmel PHONE NO : 1 866 2851656
362 Elm Street SE DECISION MADE: 21-AUG-20
Marlborough MA 01752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TaiChiA
Our United Corporation 510(k) NO: K193207(Traditional)
ATTN: Qi Liu PHONE NO : 86 15389 012257
3rd Floor, Unit 1, Block 28, ShouCSE DECISION MADE: 07-AUG-20
Xi'an CN 710018 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HYPER DLR
Shanghai United Imaging Healthcare510(k) NO: K193210(Traditional)
ATTN: Shumei Wang PHONE NO : 86 216707 68886776
No. 2258 Chengbei Road, Jiading InSE DECISION MADE: 04-AUG-20
Shanghai CN 201807 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Universal Cylinder Applicator Family
Varian Medical Systems, Inc. 510(k) NO: K193240(Traditional)
ATTN: Peter J. Coronado PHONE NO : 650 4246320
911 Hansen Way SE DECISION MADE: 17-AUG-20
Palo Alto CA 94304 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LATITUDE EV™ Total Elbow Arthroplasty
Tornier Inc. 510(k) NO: K193247(Traditional)
ATTN: Renee Stoffel PHONE NO : 952 6837471
10801 Nesbitt Ave South SE DECISION MADE: 05-AUG-20
Bloomington MN 55347 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: U-Cem Premium & MAZIC Cem
Vericom Co., Ltd. 510(k) NO: K193260(Traditional)
ATTN: Yun Ki Kim PHONE NO : 82 31 4412881
48, Toegyegongdan 1-Gil, SE DECISION MADE: 21-AUG-20
Chuncheon-Si KR 200-944 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable High Speed Air Turbine Handpiece
Ningbo HPDOVE Dental Instruments C510(k) NO: K193264(Traditional)
ATTN: Liyue Huang PHONE NO : 86 574 63883911
No.588 Xiaolin Road, Xiaolin Town SE DECISION MADE: 11-AUG-20
Cixi City CN 315321 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MedSource CathMED IV Catheter
MedSource Labs 510(k) NO: K193278(Traditional)
ATTN: Emilie Andrews PHONE NO : 952 4720131
4201 Norex Drive SE DECISION MADE: 07-AUG-20
Chaska MN 55318 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UNIKO PointCloud™ Knee Instruments
Unik Orthopedics, Inc. 510(k) NO: K193312(Traditional)
ATTN: Charlie Chi PHONE NO : 408 8875842
1701 Fortune Drive, Unit E SE DECISION MADE: 12-AUG-20
San Jose CA 95131 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Distinct® Early Detection Pregnancy Test
Acon Laboratories Inc. 510(k) NO: K193318(Traditional)
ATTN: Qiyi Xie PHONE NO : 858 8758011
5850 Oberlin Drive #340 SE DECISION MADE: 20-AUG-20
San Diego CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Med-link Reusable Temperature Probes, Med-link Disposable Temperature Probes
Shenzhen Med-link Electronics Tech510(k) NO: K193338(Traditional)
ATTN: Fei Liu PHONE NO : 0086 75561 568825 887
4th and 5th Floor, Building Two, HSE DECISION MADE: 25-AUG-20
Shenzhen CN 518109 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Electrodes Handpieces for Mygen V-1000 RF System
RF Medical Co., Ltd 510(k) NO: K193355(Special)
ATTN: Kwang S Choi PHONE NO : 82 2 21084200
#502, 503, 506, 511, 254, BeotkkotSE DECISION MADE: 03-AUG-20
Seoul KR 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Intimate Rose Kegel Exercise System
Plus EV Holdings dba Intimate Rose510(k) NO: K193364(Traditional)
ATTN: Aaron Wilt PHONE NO : 816 8056722
1700 Iron St. SE DECISION MADE: 24-AUG-20
North Kansas City MO 64116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sirona Dental CAD/CAM System with CEREC Chairside Software
Dentsply Sirona 510(k) NO: K193408(Traditional)
ATTN: Karl Nittinger PHONE NO : 717 8494424
221 West Philadelphia St., Suite 6SE DECISION MADE: 16-AUG-20
York PA 17401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Exeter V40 Femoral Stem, Exeter X3 RimFit Cup
Howmedica Osteonics Corp 510(k) NO: K193429(Traditional)
ATTN: Alexandra Kirby PHONE NO : 201 8315963
325 Corporate Drive SE DECISION MADE: 13-AUG-20
Mahwah NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VariLymph 12 pro
SLK Medical GmbH 510(k) NO: K193476(Traditional)
ATTN: Matthew Reid PHONE NO : 49 163 7550203
Oberste-Wilms-Str. 15a SE DECISION MADE: 19-AUG-20
Dortmund DE 44309 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 23andMe Personal Genome Service (PGS) Pharmacogenetic Reports
23andMe, Inc. 510(k) NO: K193492(Traditional)
ATTN: Lisa Charter PHONE NO : 650 9339455
223 N Mathilda Ave SE DECISION MADE: 17-AUG-20
Sunnyvale CA 94086 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: iMedium Single Step; iMedium Single Step with HSA; iMedium Single Step with rHA
Kitazato Corporation 510(k) NO: K193522(Traditional)
ATTN: Futoshi Inoue PHONE NO :
81 Nakajima SE DECISION MADE: 25-AUG-20
Fuji-shi JP 416-0907 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Omnichroma Flow
Tokuyama Dental Corporation 510(k) NO: K193537(Traditional)
ATTN: Keith A. Barritt PHONE NO : 11 81 338352261
38-9 Taitou 1-chome, Taitou-ku SE DECISION MADE: 19-AUG-20
Tokyo JP 110-0016 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Corin Optimized Positioning System (OPS) Femoral
Corin USA 510(k) NO: K193545(Traditional)
ATTN: Lucinda Gerber PHONE NO : 1 813 9774469
12750 Citrus Park Lane Suite 120 SE DECISION MADE: 04-AUG-20
Tampa FL 33625 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Medline ReNewal Reprocessed Harmonic ACE+7 Shears
Surgical Instrument Service and Sa510(k) NO: K193563(Traditional)
ATTN: Gail Gassner PHONE NO : 541 9233310
1500 NE Hemlock Ave SE DECISION MADE: 19-AUG-20
Redmond OR 97756 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Non-spermicidal Lubricated Male Latex Condom
Global Protection Corp. 510(k) NO: K193578(Abbreviated)
ATTN: Christina Cataldo PHONE NO : 617 9462800
12 Channel Street SE DECISION MADE: 20-AUG-20
Boston MA 02210 510(k) STATEMENT
DEVICE: TrueTear Intranasal Tear Neurostimulator
Allergan 510(k) NO: K193589(Traditional)
ATTN: Barbara Simon PHONE NO : 714 2464393
2525 Dupont Drive SE DECISION MADE: 31-AUG-20
Irvine CA 92612 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Indigo Aspiration System - Aspiration Catheter 7 and Separator 7
Penumbra, Inc. 510(k) NO: K193595(Traditional)
ATTN: Teri Nguyen PHONE NO : 510 9952012
One Penumbra Place SE DECISION MADE: 19-AUG-20
Alameda CA 94502 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Masimo Rad-97 Pulse CO-Oximeter and Accessories
Masimo Corporation 510(k) NO: K193626(Traditional)
ATTN: Linus Park PHONE NO : 949 2977000
52 Discovery SE DECISION MADE: 10-AUG-20
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Hydrophilic Coating Guide Wire
Suzhou Hengrui Disheng Medical Co.510(k) NO: K193653(Traditional)
ATTN: Ling Li PHONE NO : 86 512 68050607
No. 11 Building, No.8 Jinfeng RoadSE DECISION MADE: 26-AUG-20
Suzhou 215163 CN 215163 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Powder-Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy and Fentanyl) – Regular Cuff; Powder-Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy Drugs and Fentanyl) - Extended Cuff
Medline Industries, Inc. 510(k) NO: K193666(Traditional)
ATTN: Leontyne Banks PHONE NO : 847 9311484
Three Lakes Drive SE DECISION MADE: 04-AUG-20
Northfield IL 60093 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Adaptive Biotechnologies clonoSEQ Assay
Adaptive Biotechnologies Corporati510(k) NO: K200009(Traditional)
ATTN: Megan Duncan PHONE NO : 206 6932245
1551 Eastlake Ave E., Ste 200 SE DECISION MADE: 05-AUG-20
Seattle WA 98102 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HemosIL von Willebrand Factor Antigen
Instrumentation Laboratory Co. 510(k) NO: K200033(Special)
ATTN: Nikita Malladi PHONE NO : 781 6743245
180 Hartwell Road SE DECISION MADE: 19-AUG-20
Bedford MA 01730 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OsteoFlo NanoPutty-Quadphasic Synthetic Bone Graft
SurGenTec, LLC 510(k) NO: K200064(Traditional)
ATTN: Travis Greenhalgh PHONE NO : 516 9907882
911 Clint Moore Rd SE DECISION MADE: 14-AUG-20
Boca Raton FL 33487 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Synthetic Nitrile Patient Exam Gloves, Powder Free, Blue, Tested for Use w/Chemotherapy Drug
Anhui lntco Medical Products Co., 510(k) NO: K200093(Traditional)
ATTN: Jacken Cai PHONE NO : 86 138 53653818
No. 1 Haitang Road, Suixi DistrictSE DECISION MADE: 20-AUG-20
Huaibei City CN 235100 510(k) STATEMENT
DEVICE: hCG Urine Test Strip, hCG Urine Test Cassette, hCG Urine Test Midstream
Safecare Biotech (Hangzhou) Co., L510(k) NO: K200133(Traditional)
ATTN: Selina Zhang PHONE NO : 86 571 89712897
18 Haishu Road, Yuhang District SE DECISION MADE: 13-AUG-20
Hangzhou CN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sirona Dental CAD/CAM System with InLab Software
Dentsply Sirona 510(k) NO: K200191(Traditional)
ATTN: Karl J. Nittinger PHONE NO : 717 8494424
221 West Philadelphia St., Suite 6SE DECISION MADE: 19-AUG-20
York PA 17401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 4K UHD Camera System
Scivita Medical Technology Co., Lt510(k) NO: K200216(Traditional)
ATTN: Ruqin Wu PHONE NO : 86 512 81877788
No.8, ZhongTian Xiang, Suzhou InduSE DECISION MADE: 21-AUG-20
Suzhou CN 215000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NHancer Rx
IMDS Operations B.V. 510(k) NO: K200324(Traditional)
ATTN: E Schulting PHONE NO : 31 508 200230
Ceintuurbaan Noord 150 SE DECISION MADE: 06-AUG-20
Roden NL 9301 NA 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PlasmaFlight
ManaMed, Inc. 510(k) NO: K200351(Traditional)
ATTN: Trevor Theriot PHONE NO : 702 7811117
5240 W. Charleston Blvd SE DECISION MADE: 05-AUG-20
Las Vegas NV 89146 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ManaFlow
ManaMed, Inc 510(k) NO: K200353(Traditional)
ATTN: Trevor Theriot PHONE NO : 702 7811117
5240 W. Charleston Blvd SE DECISION MADE: 06-AUG-20
Las Vegas NV 89146 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NuEra Tight, NuEra Tight EMS
Bios s.r.l. 510(k) NO: K200359(Traditional)
ATTN: Maurizio Bianchi PHONE NO : 39 02 27304275
Via Guido Rossa 10/12 SE DECISION MADE: 11-AUG-20
Vimodrone IT 20090 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OES Elite Ureteroscopes and Accessories
Olympus Winter & Ibe GmbH 510(k) NO: K200369(Traditional)
ATTN: Stefanie Weber PHONE NO : 49 40 669663640
Kuehnstr. 61 SE DECISION MADE: 28-AUG-20
Hamburg DE 22045 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Deltaven Fast Flash Closed I.V. Catheter Systems
Delta Med Spa 510(k) NO: K200373(Traditional)
ATTN: Raschi Olga PHONE NO : 39 0375 785915
Via Guido Rossa, 20 SE DECISION MADE: 26-AUG-20
Viadana IT 46019 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Orion
interacoustics A/S 510(k) NO: K200529(Traditional)
ATTN: Erik Nielsen PHONE NO : 45 63713555
Audiometer Alle 1 SE DECISION MADE: 12-AUG-20
Middelfart DK DK-5500 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VisualEyes
Interacoustics A/S 510(k) NO: K200534(Traditional)
ATTN: Erik Nielson PHONE NO : 45 6 3713555
Audiometer Alle 1 SE DECISION MADE: 12-AUG-20
Middelfart DK 5500 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Straumann TLX Implant System
Institut Straumann AG 510(k) NO: K200586(Traditional)
ATTN: Renate Reiss PHONE NO : 41 61965 1259
Peter Merian Weg 12 SE DECISION MADE: 20-AUG-20
Basel CH 4002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VERASENSE for Exactech Equinoxe Size 38 mm, VERASENSE for Exactech Equinoxe Size 42 mm, LinkStation MINI, LinkStation MINI Evaluation Kit, VERASENSE Software Application for Shoulder
OrthoSensor, Inc. 510(k) NO: K200587(Traditional)
ATTN: Deborah Escobar Johnson PHONE NO : 954 5777770
1855 Griffin Road Suite A-310 SE DECISION MADE: 25-AUG-20
Dania Beach FL 33004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GS Medical AnyPlus PEEK Cage System
GS Medical Co., Ltd. 510(k) NO: K200592(Traditional)
ATTN: Andrea Watt PHONE NO : 949 3806385
90, Osongsaengmyeong 4-ro SE DECISION MADE: 10-AUG-20
Osong-eup, Cheongwon-gun KR 363-9510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Straumann BLX Gold Abutments
Straumann USA, LLC (On behalf of 510(k) NO: K200597(Traditional)
ATTN: Chanrasmey White PHONE NO : 978 7472614
60 Minuteman Road SE DECISION MADE: 19-AUG-20
Andover MA 01810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EKOS PE Endovascular Device with Control System 4.0 (CS4.0)
EKOS Corporation 510(k) NO: K200648(Special)
ATTN: Joshua Kim PHONE NO : 425 4153114
11911 North Creek Parkway S SE DECISION MADE: 17-AUG-20
Bothell WA 98011 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Arm-Type Fully Automatic Digital Blood Pressure Monitor
Joytech Healthcare Co., Ltd 510(k) NO: K200649(Traditional)
ATTN: Ren Yunhua PHONE NO : 86 571 81957767
No.365, Wuzhou Road, Yuhang EconomSE DECISION MADE: 03-AUG-20
Hangzhou CN 311100 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EyeArt
Eyenuk, Inc 510(k) NO: K200667(Traditional)
ATTN: Kaushal Solanki PHONE NO : 818 8353585
5850 Canoga Ave. Suite 250 SE DECISION MADE: 03-AUG-20
Los Angeles CA 91367 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MATRx plus
Zephyr Sleep Technologies 510(k) NO: K200695(Traditional)
ATTN: Sabina Bruehlmann PHONE NO : 587 3171976
102, 701 64 Ave SE SE DECISION MADE: 24-AUG-20
Calgary CA T2H-2C3 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AVIEW
Coreline Soft Co., Ltd 510(k) NO: K200714(Traditional)
ATTN: Hyeyi Park PHONE NO : 82 2 5717321
4, 5F (Yeonnam-dong) 49, World CupSE DECISION MADE: 26-AUG-20
Seoul KR 03391 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HD Video Rhino Laryngoscope
KARL STORZ Endoscopy - America, In510(k) NO: K200740(Traditional)
ATTN: Irina Fedorov PHONE NO : 508 2481275
2151 E. Grand Avenue SE DECISION MADE: 11-AUG-20
El Segundo CA 90245 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Osteo-site Vertebral Balloon
IZI Medical 510(k) NO: K200763(Traditional)
ATTN: Qiang Cao PHONE NO : 410 5949403
5 Easter Court, Suite J SE DECISION MADE: 12-AUG-20
Owings Mills MD 21117 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LOOP LED Curing Light System
Garrison Dental Solutions, LLC 510(k) NO: K200775(Traditional)
ATTN: Alex Hull PHONE NO : 616 8422244
150 DeWitt Lane SE DECISION MADE: 14-AUG-20
Spring Lake MI 49456 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: XBit Series Digital Color Doppler Ultrasound System
CHISON Medical Technologies Co., L510(k) NO: K200780(Traditional)
ATTN: Qifei Liu PHONE NO : 0086 510 85311707
No.228, Changjiang East Road, BlocSE DECISION MADE: 05-AUG-20
Wuxi CN 214142 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Emprint Ablation System with Thermosphere Technology
Covidien LLC 510(k) NO: K200796(Traditional)
ATTN: Liron Bar yaakov PHONE NO : 303 5816668
5920 Longbow Drive SE DECISION MADE: 26-AUG-20
Boulder CO 80301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: D-LUX+
Diadent Group International 510(k) NO: K200809(Traditional)
ATTN: Kab Sun Lee PHONE NO : 82 43 2662315
16, Osongsaengmyeong 4-ro, Osong-eSE DECISION MADE: 07-AUG-20
Cheongji-si KR 28161 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Braid
Braid.Health 510(k) NO: K200822(Traditional)
ATTN: Vivian Liu PHONE NO : 617 3356866
301 Rhode Island St. SE DECISION MADE: 13-AUG-20
San Francisco CA 94103 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Tyece OTC TENS Model
Tyece Limited 510(k) NO: K200838(Traditional)
ATTN: Parshid Falahati PHONE NO : 852 2 3497456
Unit 803, Block A, Po Lung Centre,SE DECISION MADE: 12-AUG-20
Kowloon CN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Stimulator, Stimulator Kit, External Transmitter, External Transmitter Kit
Micron Medical Corporation 510(k) NO: K200848(Traditional)
ATTN: Elizabeth Greene PHONE NO : 888 6910585
606 Banyan Trail SE DECISION MADE: 14-AUG-20
Boca Raton FL 33431 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Mini Sterilizable Tray
Implant Direct Sybron Manufacturin510(k) NO: K200858(Traditional)
ATTN: Reina Choi PHONE NO : 818 4443306
3050 East Hillcrest Drive SE DECISION MADE: 06-AUG-20
Thousand Oaks CA 91362 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Infinity M300
Draeger Medical Systems, Inc. 510(k) NO: K200859(Traditional)
ATTN: Thomas Ostrowski PHONE NO : 978 3798002
6 Tech Dr. SE DECISION MADE: 28-AUG-20
Andover MA 01810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Oral-B iO Test Drive Power Brush Trial Program Kit
The Proctor & Gamble Company 510(k) NO: K200881(Traditional)
ATTN: Michael A. Kaminski PHONE NO : 513 6222879
1 Proctor & Gamble Plaza SE DECISION MADE: 27-AUG-20
Cincinnati OH 45202 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Invacare Perfecto2V Oxygen Concentrator
Invacare Corporation 510(k) NO: K200890(Traditional)
ATTN: Elijah Wreh PHONE NO : 440 3296840
One Invacare Way SE DECISION MADE: 06-AUG-20
Elyria OH 44035 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Univers Revers Modular Glenoid System, Half Augment Baseplate
Arthrex Inc. 510(k) NO: K200895(Traditional)
ATTN: Ivette Galmez PHONE NO : 1 239 6435553 71263
1370 Creekside Boulevard SE DECISION MADE: 13-AUG-20
Naples FL 34108-1945 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Single-use Surgical Mask
BYD Precision Manufacturer Co.Ltd.510(k) NO: K200923(Traditional)
ATTN: Yubo Guan PHONE NO : 86 755 89888888 68765
No.3001 Baohe Road, Baolong IndustSE DECISION MADE: 26-AUG-20
Shenzhen CN 518116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OrthoGold 100
Tissue Regeneration Technologies, 510(k) NO: K200926(Traditional)
ATTN: John Warlick PHONE NO :
251 Heritage Walk SE DECISION MADE: 28-AUG-20
Woodstock GA 30188 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Electronic Blood Pressure Monitor
Jiangsu Yuyue Medical Equipment & 510(k) NO: K200939(Special)
ATTN: Rui Li PHONE NO : 86 025855 82701 6225
Yunyang Industrial Park SE DECISION MADE: 20-AUG-20
Danyang CN 212300 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Glaucoma Module
Topcon Healthcare Solutions, Inc. 510(k) NO: K200954(Traditional)
ATTN: Ramya Sundaram PHONE NO : 201 5995553
111 Bauer Drive SE DECISION MADE: 03-AUG-20
Oakland NJ 07436 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Brainsway Deep TMS System
Brainsway Ltd. 510(k) NO: K200957(Traditional)
ATTN: Ahava Stein PHONE NO : 972 5464 20642
19 Hartom St. (Bynet Bldg) Har HotSE DECISION MADE: 21-AUG-20
Jerusalem IL 9777518 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODULIF-A Anterior Lumbar Interbody Fusion System
Spinal Stability, LLC 510(k) NO: K200958(Traditional)
ATTN: David Krueger PHONE NO : 512 6335313
104 Hensley Circle SE DECISION MADE: 28-AUG-20
Austin TX 78738 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Synapse 3D Cardiac Tools
FUJIFILM Corporaton 510(k) NO: K200973(Traditional)
ATTN: Randy Vader PHONE NO : 360 3566821
26-30,Nishiazabu 2-Chome Minato-KuSE DECISION MADE: 27-AUG-20
Tokyo JP 106-8620 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Modular Toga
Operating Room Innovations, Inc. 510(k) NO: K200977(Traditional)
ATTN: Mark McBride PHONE NO : 619 2100725
5694 Mission Center Road Ste 602 SE DECISION MADE: 05-AUG-20
San Diego CA 92108 510(k) STATEMENT
DEVICE: Mega Plus MIS Spine System
BK Meditech, Co., Ltd 510(k) NO: K200981(Traditional)
ATTN: Byoungjun Park PHONE NO : 82 313529 135
58, Eunhaengnamu-ro, Yanggam-myeonSE DECISION MADE: 11-AUG-20
Hwaseong-si KR 18633 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VIDA|vision
VIDA Diagnostics Inc. 510(k) NO: K200990(Traditional)
ATTN: Sandra Stapleton PHONE NO : 1 855 9008432
2500 Crosspark Rd, W250 BioVentureSE DECISION MADE: 07-AUG-20
Coralville IA 52241 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: K2M Navigation Instruments
K2M, Inc. 510(k) NO: K201006(Special)
ATTN: Oonagh Lahiff PHONE NO :
600 Hope Parkway SE SE DECISION MADE: 07-AUG-20
Leesburg VA 20175 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Infinix Universal Composite, Infinix Flowable Composite, Infinix Bulk Fill Flow Composite
Nobio Ltd. 510(k) NO: K201010(Traditional)
ATTN: Galit Gershon PHONE NO : 972 9 7893000
8 Hamatechet St. SE DECISION MADE: 14-AUG-20
Kadima IL 6092000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BriefCase
Aidoc Medical, Ltd. 510(k) NO: K201020(Traditional)
ATTN: Nimrod Epstein PHONE NO : 972 73 7946870
3 Aminadav St. SE DECISION MADE: 26-AUG-20
Tel-Aviv IL 6706703 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KLS Martin Individual Patient Solutions (IPS) Planning System
KLS-Martin L.P. 510(k) NO: K201052(Traditional)
ATTN: Jennifer Damato PHONE NO : 800 6251557
11201 Saint Johns Industrial ParkwSE DECISION MADE: 31-AUG-20
Jacksonville FL 32246 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SOMNscreenn plus
Somnomedics GmbH 510(k) NO: K201054(Traditional)
ATTN: Stephanie Wolski PHONE NO : 49 931 35909462
Am Sonnenstuhl 63 SE DECISION MADE: 12-AUG-20
Randersacker DE 97236 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NeuroBlate System
Monteris Medical, Inc. 510(k) NO: K201056(Traditional)
ATTN: David H. Mueller PHONE NO : 763 2534710
14755 27th Avenue North; Suite C SE DECISION MADE: 21-AUG-20
Plymouth MN 55447 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CUPID Brand Male Natural Rubber Latex Condoms (Plain (banana) , Plain (strawberry), Dotted , Multi-textured (Dotted+Contoured + Ribbed))
CUPID Limited 510(k) NO: K201067(Abbreviated)
ATTN: Durgesh Garg PHONE NO : 91 95525 99276
A-68, M.I.D.C. (Malegaon), Sinnar SE DECISION MADE: 07-AUG-20
Nashik IN 422113 510(k) STATEMENT
DEVICE: Anchor Dual Lumen Guidewire Catheter
Aqure Medical, Inc. 510(k) NO: K201076(Third Party - Traditional)
ATTN: Jie Xia PHONE NO : 612 2033270
12560 Flethcer Lane, Suite 300 SE DECISION MADE: 06-AUG-20
Rogers MN 55374 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: Aurora® Anterior Lumbar Plate Sytstem
Prism Surgical Design Pty Ltd. 510(k) NO: K201079(Traditional)
ATTN: Emma May Young PHONE NO : 61 73 7208882
15/43 Lang Parade SE DECISION MADE: 05-AUG-20
Milton AU 4064 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD PhaSeal Optima Closed System Drug Transfer Device
Becton, Dickinson and Company 510(k) NO: K201099(Special)
ATTN: Amy Honey PHONE NO : 385 2465164
1 Becton Drive SE DECISION MADE: 12-AUG-20
Franklin Lakes NJ 07417 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Next Generation Balloon Dilation System
Acclarent Inc. 510(k) NO: K201115(Traditional)
ATTN: David Locke PHONE NO : 419 2332611
31 Technology Dr., Suite 200 SE DECISION MADE: 27-AUG-20
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Asept Surgical Face Mask
PFM Medical, Inc 510(k) NO: K201137(Abbreviated)
ATTN: Jessica Jho PHONE NO : 801 4559267
1916 Palomar Oaks Way, Suite 150 SE DECISION MADE: 19-AUG-20
Carlsbad CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FIRMM
Nous Imaging, Inc. 510(k) NO: K201141(Traditional)
ATTN: Todd Deckard PHONE NO : 612 3603493
4220 Duncan Ave SE DECISION MADE: 26-AUG-20
St. Louis MO 63108 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VICRYL Mesh
Ethicon, Inc. 510(k) NO: K201143(Traditional)
ATTN: Valerie Smith Beyer PHONE NO : 908 2182583
Route 22 West, P.O. Box 151 SE DECISION MADE: 06-AUG-20
Somerville NJ 08876-0151 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WallFlex Colonic Stent System with Anchor Lock Delivery System
Boston Scientific Corporation 510(k) NO: K201159(Traditional)
ATTN: Catherine Sanford PHONE NO : 508 6834498
100 Boston Scientific Way SE DECISION MADE: 17-AUG-20
Marlborough MA 01752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Essence 55SP Large Monitor System
Shenyang Torch-Bigtide Digital Tec510(k) NO: K201162(Traditional)
ATTN: Fu Ailing PHONE NO : 86 24 88087606
No. 18-6B, Yaoyang Road, Huishan ESE DECISION MADE: 27-AUG-20
Shenyang CN 110164 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Temno Elite Biopsy System
Merit Medical Systems, Inc 510(k) NO: K201166(Traditional)
ATTN: Niloufar Samimi PHONE NO : 801 2084583
1600 West Merit Parkway SE DECISION MADE: 28-AUG-20
South Jordan UT 84095 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ECG Monitor App
Samsung Electronics Co., Ltd 510(k) NO: K201168(Traditional)
ATTN: Taejong Jay Yang PHONE NO : 82 31 2795590
129, Samsung-ro, Yeongtong-gu, SE DECISION MADE: 04-AUG-20
Suwon-si KR 16677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TruDi Curette
Acclarent, Inc. 510(k) NO: K201174(Traditional)
ATTN: Leena Sorathia PHONE NO : 1 949 9234118
31 Technology Drive SE DECISION MADE: 12-AUG-20
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RadGil2
R3 X-Ray L.L.C 510(k) NO: K201177(Traditional)
ATTN: Robert Hase PHONE NO : 520 7710882
2730 E. Broadway BLVD STE 160 SE DECISION MADE: 17-AUG-20
Tucson AZ 85716 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Jada System
Alydia Health 510(k) NO: K201199(Traditional)
ATTN: Colby Holtshouse PHONE NO : 650 2753772
3495 Edison Way SE DECISION MADE: 28-AUG-20
Menlo Park CA 94025 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HemoCue Hb 301 System
HemoCue AB 510(k) NO: K201217(Traditional)
ATTN: Maria Fagerberg PHONE NO : 46 43148 1346
Kuvettgatan 1 SE DECISION MADE: 04-AUG-20
Angelholm SE 26271 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Limbus Contour
Limbus AI Inc. 510(k) NO: K201232(Traditional)
ATTN: Jon Giambattista PHONE NO : 306 5025982
2076 Athol St SE DECISION MADE: 13-AUG-20
Regina CA SK S4T 3E5 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Mariner Cap System
SeaSpine Orthopedics Corporation 510(k) NO: K201240(Traditional)
ATTN: Alicia McArthur PHONE NO : 760 2165117
5770 Armada Drive SE DECISION MADE: 05-AUG-20
Carlsbad CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Concorde Models Concorde US and Concorde ST Soft Tissue Biopsy Devices
TransMed7, LLC 510(k) NO: K201244(Special)
ATTN: James Vetter PHONE NO : 1 650 4000101
117 Solana Road SE DECISION MADE: 07-AUG-20
Portola Valley CA 94028 510(k) STATEMENT
DEVICE: Syringe Holder accessory
Vapocoolshot, Inc. 510(k) NO: K201248(Traditional)
ATTN: Jacob Leibovici PHONE NO : 561 4270420
1155 Main Street, suite 105 SE DECISION MADE: 12-AUG-20
Jupiter FL 33458 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CarboClear Navigated Instruments
CarboFix Orthopedics Ltd. 510(k) NO: K201251(Traditional)
ATTN: Hila Wachsler-Avrahami PHONE NO : 972 9 9511511
11 Ha'hoshlim St. SE DECISION MADE: 05-AUG-20
Herzeliya IL 4672411 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Adaptix Interbody System with Titan nanoLOCK Surface Technology
Medtronic Sofamor Danek 510(k) NO: K201267(Traditional)
ATTN: Diamond Wallace PHONE NO : 901 3992757
1800 Pyramid Place SE DECISION MADE: 26-AUG-20
Memphis TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 0.9% Sodium Chloride I.V. Flush Syringe for Sterile Delivery, 1 syringe/pouch, 0.9% Sodium Chloride I.V. Flush Syringe for Sterile Delivery, 2 syringes/pouch
Nurse Assist, LLC 510(k) NO: K201286(Traditional)
ATTN: Romeo Crisologo PHONE NO : 817 2311300 215
4409 Haltom Road SE DECISION MADE: 11-AUG-20
Haltom City TX 76117 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Accipiolx
MaxQ Al Ltd. 510(k) NO: K201310(Traditional)
ATTN: Joshua Schulman PHONE NO : 1 617 7786839
96 Yigal Alon Street, 1st Floor SE DECISION MADE: 07-AUG-20
Tel Aviv IL 6789140 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Keystone Dental XL Dental Implant System
Keystone Dental Inc. 510(k) NO: K201334(Traditional)
ATTN: Linda Jalbert PHONE NO : 781 3283660
154 Middlesex Turnpike SE DECISION MADE: 18-AUG-20
Burlington MA 01803 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 3D Auto LAA
Philips Healthcare 510(k) NO: K201352(Traditional)
ATTN: Travis Catania PHONE NO : 908 2279423
22100 Bothell Everett Highway SE DECISION MADE: 17-AUG-20
Bothell WA 98021-8431 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Reusable and Disposable SpO2 Sensors
Xinkang Medical Instrument Co. Ltd510(k) NO: K201360(Traditional)
ATTN: Xu Changsheng PHONE NO : 86 755 23776681
2 Floor, Puhua S&T Park, TongshengSE DECISION MADE: 19-AUG-20
Shenzhen CN 518109 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CD Horizon™ Fenestrated Screw Set, CD Horizon™ Spinal System, Kyphon™ HV-R™ Bone Cement
Medtronic 510(k) NO: K201362(Traditional)
ATTN: Shweta Sharma PHONE NO : 901 3992425
1800 Pyramid Place SE DECISION MADE: 19-AUG-20
Memphis TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HOPKINS ICG/NIR 10mm Ridgid Endoscope (modified) 0°, 30°, 45°, HOPKIN ICG/NIR 5mm Ridgid Endoscope (modified) 0°, 30°, 45°, HOPKIN ICG/NIR 4mm Ridgid Endoscope 0°, 30°, 45°, VITOM II ICG/NIR Telescope, Power LED Rubina Light Source, Foot Switch, Fiber Optic Light Cable, Image S CCU, Image S 4U Rubina Camera Head
Karl Storz-Endoscopy-America, Inc.510(k) NO: K201399(Traditional)
ATTN: Alita McElroy PHONE NO : 424 2188376
2151 E. Grand Avenue SE DECISION MADE: 17-AUG-20
El Segundo CA 90245 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LabPro Data Management System
Beckman Coulter Inc. 510(k) NO: K201405(Traditional)
ATTN: Christina Thomas PHONE NO : 737 7018790
1584 Enterprise Blvd SE DECISION MADE: 30-AUG-20
West Sacramento CA 95691 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Masimo O3 Regional Oximeter System
Masimo Corporation 510(k) NO: K201432(Traditional)
ATTN: Sindura Penubarthi PHONE NO : 949 2977541
52 Discovery SE DECISION MADE: 29-AUG-20
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Syngo.via RT Image Suite
Siemens Medical Solutions USA, Inc510(k) NO: K201444(Traditional)
ATTN: Cynthia Busch PHONE NO : 847 6436818
2501 N Barrington Rd. SE DECISION MADE: 13-AUG-20
Hoffman Estate IL 60192 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VenSure Balloon Device, VenSure Nav Balloon Device
Fiagon GmbH 510(k) NO: K201472(Traditional)
ATTN: Dirk Mucha PHONE NO : 49 3302 2012124
Neuendorfstr. 23b SE DECISION MADE: 26-AUG-20
Hennigsdorf DE 16761 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DreaMed Advisor Pro
DreaMed Diabetes Ltd 510(k) NO: K201476(Traditional)
ATTN: Inbal Beinglass Peled PHONE NO : 972 5236 42760
5 Mota Gur St SE DECISION MADE: 28-AUG-20
Petah Tikva IL 4952701 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Life Spine Plateau-A Ti Anterior Lumbar Spacer & Plateau-X Ti Lateral Lumbar Spacer
Life Spine Inc. 510(k) NO: K201500(Traditional)
ATTN: Angela Batker PHONE NO : 847 8846117
13951 S Quality Drive SE DECISION MADE: 04-AUG-20
Huntley IL 60142 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vitra 810
Quantel Medical 510(k) NO: K201502(Traditional)
ATTN: Bruno Pages PHONE NO : 33 473 745732
11 Rue du Bois Joli-CS40015 SE DECISION MADE: 06-AUG-20
Cournon D'Auvergne-Cedex FR 63808510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Simplexa Flu A/B & RSV Direct Gen II, Simplexa Flu A/B & RSV Positive Control Pack
DiaSorin Molecular LLC 510(k) NO: K201505(Traditional)
ATTN: Sharon Young PHONE NO : 562 2406500
11331 Valley View Street SE DECISION MADE: 22-AUG-20
Cypress CA 90630 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Quantra QPlus System
HemoSonics, LLC 510(k) NO: K201513(Special)
ATTN: Anne Zavertnik PHONE NO : 434 2021032 100
400 Preston Avenue, Suite 250 SE DECISION MADE: 21-AUG-20
Charlottesville VA 22903 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Route 92 Medical 088 Access System
Route 92 Medical 510(k) NO: K201518(Traditional)
ATTN: Kathy Tansey PHONE NO : 650 5811179
155 Bovet Road, Suite 100 SE DECISION MADE: 14-AUG-20
San Mateo CA 94402 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Medina Anterior Cervical Plate System
Alliance Partners, LLC 510(k) NO: K201521(Traditional)
ATTN: Desiree Crawford PHONE NO : 210 3142525 213
14206 Northbrook Drive SE DECISION MADE: 06-AUG-20
San Antonio TX 78232 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Fusion Dark Grey)
Hartalega Ngc Sdn. Bhd. 510(k) NO: K201530(Traditional)
ATTN: Kuan Mun Leong PHONE NO : 603 62771733
Kawasan Perindustrian Tanjung SE DECISION MADE: 05-AUG-20
Sepang MY 43900 510(k) STATEMENT
DEVICE: Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue)
Hartalega SDN. BHD. 510(k) NO: K201531(Traditional)
ATTN: Kuan Kam Hon PHONE NO : 603 62771773
Dataran SD PJU9 SE DECISION MADE: 05-AUG-20
Bandar Sri Damansara MY 52200 510(k) STATEMENT
DEVICE: Motex Anti-Fog Surgical Face Mask
Modern Healthcare Corp. 510(k) NO: K201549(Traditional)
ATTN: Ke-Min Jen PHONE NO : 886 4 875116
NO. 751, Sec. 2, Chung-Chou Rd., SE DECISION MADE: 26-AUG-20
Tien-Chung Town, Chang-Hwa County 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Precice® Bone Transport System
NuVasive Specialized Orthopedics, 510(k) NO: K201567(Traditional)
ATTN: Madison Heffron PHONE NO : 949 5327868
101 Enterprise, Suite 100 SE DECISION MADE: 10-AUG-20
Aliso Viejo CA 92656 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Monterey AL Interbody System
Stryker Corporation 510(k) NO: K201585(Traditional)
ATTN: Alexia Haralambous PHONE NO : 201 7498518
2 Pearl Court SE DECISION MADE: 10-AUG-20
Allendale NJ 07401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CRYOCARE TOUCH System and Accessories, Endocare 1.7mm Round Ice PerCryo Cryoprobe, Short, Round Ice
Varian Medical Systems, Inc. 510(k) NO: K201588(Traditional)
ATTN: Peter J. Coronado PHONE NO : 650 4245728
3100 Hansen Way SE DECISION MADE: 11-AUG-20
Palo Alto CA 94304 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EndoTool IV System
Monarch Medical Technologies, LLC 510(k) NO: K201619(Traditional)
ATTN: Ann Marie Gaitan PHONE NO : 704 5620777
4400 Stuart Andrew Blvd, Suite N SE DECISION MADE: 07-AUG-20
Charlotte NC 28217 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LION Photocoagulator
Norlase ApS 510(k) NO: K201623(Special)
ATTN: Jan Forstberg PHONE NO : 45 9397 7472
Brydehusvej 30 SE DECISION MADE: 11-AUG-20
2750 Ballerup DK 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TOMTEC-ARENA
TOMTEC Imaging Systems GmbH 510(k) NO: K201632(Traditional)
ATTN: Marc Bergenthal PHONE NO : 49 89 32175555
Edisonstrasse 6 SE DECISION MADE: 14-AUG-20
Unterschleissheim DE 85716 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Hercules Suture Anchor System
In2Bones USA, LLC 510(k) NO: K201636(Traditional)
ATTN: Christine Scifert PHONE NO : 901 8318053
6000 Poplar Ave, Suite 115 SE DECISION MADE: 20-AUG-20
Memphis TN 38119 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Aurora Evacuator +Coag
Rebound Therapeutics 510(k) NO: K201637(Traditional)
ATTN: Naomi Gong PHONE NO : 949 3789483
13900 Alton Parkway Suite 120 SE DECISION MADE: 12-AUG-20
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Laparoscope Trocar
Beijing Biosis Healing Biological 510(k) NO: K201641(Traditional)
ATTN: Jiali Zhou PHONE NO : 86 10 61252660
No.6 plant west, Valley No.1 Bio-mSE DECISION MADE: 06-AUG-20
Beijing CN 102600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Midmark Extraoral Imaging System (EOIS)
Midmark Corporation 510(k) NO: K201667(Traditional)
ATTN: Mark Kenar PHONE NO : 847 4159800
1001 Asbury Drive SE DECISION MADE: 06-AUG-20
Buffalo Grove IL 60089 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DC-90/DC-90S/DC-90Q/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80AExp/DC-80A Pro/DC-8X/DC-8Q/DC-81/DC-82 Diagnostic Ultrasound System
Shenzhen Mindray Bio-Medical Elect510(k) NO: K201693(Traditional)
ATTN: Zhang Wei PHONE NO : 0086 755 81885655
Mindray Building, Keji 12th Road SSE DECISION MADE: 21-AUG-20
Nanshan CN 518057 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CoFix System
Paradigm Spine GmbH 510(k) NO: K201704(Special)
ATTN: Branko Sostarko PHONE NO : 800 5579909
375 River Park Circle SE DECISION MADE: 04-AUG-20
Marquette MI 49855 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Smart Toe II, X Fuse
Stryker GmbH 510(k) NO: K201715(Traditional)
ATTN: Jemin Dedania PHONE NO : 201 8316802
325 Corporate Drive SE DECISION MADE: 05-AUG-20
Mahwah NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Hyperfine Point-Of-Care Magnetic Resonance Imaging (POC MRI) Scanner System
Hyperfine Research, Inc. 510(k) NO: K201722(Traditional)
ATTN: Robert Fasciano PHONE NO : 203 2046900
530 Old Whitfield Street SE DECISION MADE: 11-AUG-20
Guilford CT 06437 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Arthrex SwiveLock Anchor
Arthrex Inc. 510(k) NO: K201749(Traditional)
ATTN: Jessica Singelais PHONE NO : 1 239 5984302 73091
1370 Creekside Boulevard SE DECISION MADE: 21-AUG-20
Naples FL 34108-1945 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Pentaray Nav eco High-Density Mapping Catheter
Biosense Webster, Inc 510(k) NO: K201750(Traditional)
ATTN: Richard Lauhead PHONE NO : 949 7898583
33 Technology Dr SE DECISION MADE: 06-AUG-20
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nitrile Powder Free Examination Gloves with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue)
Hartalega NGC Sdn. Bhd. 510(k) NO: K201772(Traditional)
ATTN: Kuan Mun Leong PHONE NO : 603 6277 1733
No. 1, Persiaran Tanjung Kawasan PSE DECISION MADE: 25-AUG-20
Sepang MY 43900 510(k) STATEMENT
DEVICE: VersaOne Reusable Positioning Trocar System
Covidien 510(k) NO: K201805(Traditional)
ATTN: Stephanie Wilde PHONE NO : 475 3310244
60 Middletown Avenue SE DECISION MADE: 26-AUG-20
North Haven CT 06473 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ANCORIS
MiEGmbH 510(k) NO: K201807(Traditional)
ATTN: Thomas Kuehl PHONE NO : 49 419 499770
Hauptstrasse 112 SE DECISION MADE: 27-AUG-20
Seth DE 23845 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ANSER Clavicle Pin
Baat Medical Products BV 510(k) NO: K201830(Traditional)
ATTN: Teake Bulstra PHONE NO : 31 088 5656600
F. Hazemeijerstraat 800 - BuildingSE DECISION MADE: 27-AUG-20
RJ Hengelo NL 7555 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CONFIDENCE Spinal Cement System
DePuy Spine, Inc. 510(k) NO: K201831(Traditional)
ATTN: Sergio M. Cordeiro PHONE NO : 508 9772640
325 Paramount Drive SE DECISION MADE: 31-AUG-20
Raynham MA 02767-0350 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vector Hammertoe Correction System
Nvision Biomedical Technologies, I510(k) NO: K201850(Special)
ATTN: Diana Langham PHONE NO : 210 5453713
4590 Lockhill Selma SE DECISION MADE: 04-AUG-20
San Antonio TX 78249 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Provicol QM Aesthetic
VOCO GmbH 510(k) NO: K201856(Special)
ATTN: M. Th. Plaumann PHONE NO : 49 4721 7190
Anton-Flettner-Str. 1-3 SE DECISION MADE: 26-AUG-20
Cuxhaven DE 27472 510(k) STATEMENT
DEVICE: Surgical Mask
C & S Paper Yunfu Co., Ltd. 510(k) NO: K201871(Third Party - Traditional)
ATTN: Xu Zhiming PHONE NO : 86 400 6223038
No. 168 Longbao Road, Shuangdong SSE DECISION MADE: 12-AUG-20
Luoding CN 510(k) STATEMENT
THIRD PARTY REVIEW
DEVICE: 6.5 mm Healix Advance SP Peek Anchor, 6.5 mm Healix Advance SP Biocomposite Anchor
Medos International SARL 510(k) NO: K201883(Special)
ATTN: Elizabeth Messana PHONE NO : 508 8283150
Chemin-Blanc 38, Case Postale SE DECISION MADE: 07-AUG-20
Le Locle CH Ch 2400 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ClariVein IC
Merit Medical Systems, Inc. 510(k) NO: K201907(Special)
ATTN: Michaela Rivkowich PHONE NO : 801 3163632
1600 West Merit Parkway SE DECISION MADE: 06-AUG-20
South Jordan UT 84095 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Inspire 6M Hollow Fiber oxygenator, Inspire 7M Hollow Fiber oxygenator, Inspire 8M Hollow Fiber oxygenator
Sorin Group Italia S.r.l 510(k) NO: K201916(Special)
ATTN: Luigi Vecchi PHONE NO : 39 0535 29957
Via Statale 12 Nord, 86 SE DECISION MADE: 13-AUG-20
Mirandola IT 41037 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CarboClear® Pedicle Screw System, CarboClear® II Pedicle Screw System
CarboFix Orthopedics Ltd. 510(k) NO: K201926(Special)
ATTN: Hila Wachsler-Avrahami PHONE NO : 972 9 9511511
11 Ha’hoshlim St. SE DECISION MADE: 07-AUG-20
Herzeliya IL 4672411 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: X-ray Flat Panel Detectors (CareView 1800Cwe /CareView 1500Cwe)
CareRay Digital Medical System Co.510(k) NO: K201932(Special)
ATTN: Leilei Li PHONE NO : 86 512868 60288
A2-201/B3-501, Biobay, 218 Xinghu SE DECISION MADE: 07-AUG-20
SuZhou CN 215123 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ImagenSPECT 3.0
Cardiovascular Imaging Technologie510(k) NO: K201933(Special)
ATTN: James A. Case PHONE NO : 816 5312842
4320 Wornall Road, Suite 114 SE DECISION MADE: 11-AUG-20
Kansas City MO 64111 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LZI Fentanyl II Enzyme Immunoassay
Lin-Zhi International, Inc. 510(k) NO: K201938(Traditional)
ATTN: Bernice Lin PHONE NO : 408 9708811
2945 Oakmead Village Court SE DECISION MADE: 07-AUG-20
Santa Clara CA 95051 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CrossGlide ETS Plus
CrossBay Medical 510(k) NO: K201952(Special)
ATTN: Piush Vidyarthi PHONE NO : 415 7282847
13240 Evening Creek Drive, Suite 3SE DECISION MADE: 05-AUG-20
San Diego CA 92128 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OMNI PLUS Surgical System
Sight Sciences, Inc. 510(k) NO: K201953(Special)
ATTN: Edward J. Sinclair PHONE NO : 650 2189149
4040 Campbell Ave., Suite 100 SE DECISION MADE: 11-AUG-20
Menlo Park CA 94025 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ETD Family of Electrotherapy Devices
TheraSigma, LLC 510(k) NO: K201958(Third Party - Traditional)
ATTN: Jim Klett PHONE NO : 949 6899892
6040 South Grant St. Suite 100 SE DECISION MADE: 04-AUG-20
Washougal WA 98671 510(k) STATEMENT
THIRD PARTY REVIEW
DEVICE: SpaceFlex Knee - 80mm Size
G21 S.r.l 510(k) NO: K201960(Special)
ATTN: Filippo Foroni PHONE NO : 39 0535 30312
Via Sandro Petrini, 8 SE DECISION MADE: 13-AUG-20
San Possidonio IT 41039 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IlluminOss Photodynamic Bone Stabilization System
IlluminOss Medical, Inc. 510(k) NO: K201961(Special)
ATTN: Robert Rabiner PHONE NO : 401 7140008
993 Waterman Avenue SE DECISION MADE: 13-AUG-20
East Providence RI 02914 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cervical Plate System
Eminent Spine, LLC 510(k) NO: K201979(Traditional)
ATTN: Stephen Courtney PHONE NO : 972 4993593
1705 Ohio Drive, Suite 300 SE DECISION MADE: 25-AUG-20
Plano TX 75093 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Magicore System
InnoBioSurg Co., Ltd. 510(k) NO: K201981(Special)
ATTN: Bo-Yeon Lim PHONE NO : 82 42 9332879
44-19, Techno 10-ro, Yuseong-gu SE DECISION MADE: 27-AUG-20
Daejeon KR 34027 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CUBEScan BioCon-1100
Mcube Technology Co., Ltd. 510(k) NO: K201995(Special)
ATTN: Hye-Ri Choi PHONE NO : 82 02 34217780
#803, 123, Bonghwasan-ro, JungnangSE DECISION MADE: 19-AUG-20
Seoul KR 02048 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Mammotome Revolve Dual Vacuum Assisted Biopsy (VAB) System
Devicor Medical Products, Inc. 510(k) NO: K202012(Third Party - Traditional)
ATTN: Gwendolyn P. Payne PHONE NO : 513 8649186
300 E-Business Way, Fifth Floor SE DECISION MADE: 18-AUG-20
Cincinnati OH 45241 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES AquaComfort Plus (DACP) / DACP FreshTech / DACP Toric / DACP Multifocal
Alcon Laboratories, Inc. 510(k) NO: K202036(Special)
ATTN: Sherri Lakota PHONE NO : 1 817 6155472
6201 South Freeway SE DECISION MADE: 21-AUG-20
Fort Worth TX 76134-2099 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cranial 4Pi Immobilization
Brainlab AG 510(k) NO: K202050(Special)
ATTN: Chiara Cunico PHONE NO : 49 8999 15680
Olof-Palme-Str. 9 SE DECISION MADE: 19-AUG-20
Munich DE 81829 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Dynex Ring Fixation System, Diametrix Ring Fixation System
Vilex, LLC 510(k) NO: K202054(Traditional)
ATTN: Joyce Thacker PHONE NO : 931 4747550
111 Moffitt Street SE DECISION MADE: 24-AUG-20
McMinnville TN 37110 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Admiral ACP System
SeaSpine Orthopedics Corporation 510(k) NO: K202064(Traditional)
ATTN: Aly Alvarez PHONE NO : 619 8844342
5770 Armada Drive SE DECISION MADE: 26-AUG-20
Carlsbad CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: The AIO Solution 3.0
Orfit Industries NV 510(k) NO: K202068(Traditional)
ATTN: Eddy Marivoet PHONE NO : 32 03 3262026
9A, Vosveld SE DECISION MADE: 14-AUG-20
Wijnegem BE 2110 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MindsEye Expandable Port
Minnetronix Neuro, INC. 510(k) NO: K202072(Third Party - Traditional)
ATTN: Matt Adams PHONE NO : 651 2519419
1635 Energy Park Drive SE DECISION MADE: 26-AUG-20
St. Paul MN 55108 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: AOS Galileo™ Trochanteric Nail System
Advanced Orthopaedic Solutions, In510(k) NO: K202099(Special)
ATTN: Jolie Krance PHONE NO : 310 5339966
3203 Kashiwa Street SE DECISION MADE: 28-AUG-20
Torrance CA 90505 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: External Counterpulsation System, Soulaire
Vamed Medical Instrument Co., Ltd.510(k) NO: K202108(Special)
ATTN: Ji Ma PHONE NO : 86 757 83817601
1 of 8 Floor, 2# Building, No. 60,SE DECISION MADE: 28-AUG-20
Foshan CN 413200 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EzDent-i/ E2/ Prora View/ Smart M Viewer
Ewoo soft Co., Ltd. 510(k) NO: K202116(Special)
ATTN: Young Seok Kim PHONE NO : 82 31 80156172
801-ho, Vatechnetworks Bldg., 13, SE DECISION MADE: 21-AUG-20
Hwaseong-si KR 18449 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FUJIFILM Video Laparoscope
Fujifilm Corporation 510(k) NO: K202130(Special)
ATTN: Randy Vader PHONE NO : 360 3566821
798 Miyanodai Kaisei-Machi SE DECISION MADE: 20-AUG-20
Ashigarakami-Gun JP 258-8538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SpaceOAR System
Boston Scientific Corporation 510(k) NO: K202224(Special)
ATTN: Jeanne OToole PHONE NO : 508 6834271
100 Boston Scientific Way SE DECISION MADE: 28-AUG-20
Marlborough MA 01752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Penumbra System (Penumbra JET 7 Reperfusion Catheter with Xtra Flex Technology; Penumbra JET 7MAX)
Penumbra, Inc. 510(k) NO: K202251(Special)
ATTN: Anush Puvvada PHONE NO : 510 4405568
One Penumbra Place SE DECISION MADE: 31-AUG-20
Alameda CA 94502 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BracePaste Band and Build LC
American Orthodontics 510(k) NO: K202276(Third Party - Traditional)
ATTN: Andre Leak PHONE NO : 920 4575051
3524 Washington Avenue SE DECISION MADE: 14-AUG-20
Sheboygan WI 53081 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
TOTAL 510(k)s THIS PERIOD 221
TOTAL WITH SUMMARIES 208
TOTAL WITH STATEMENTS 13
