510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD January 2021
DEVICE: EndoClot
EndoClot Plus Co., Ltd. 510(k) NO: K190677(Traditional)
ATTN: Huihui Xie PHONE NO : 086 512 62605550
101 Room, B8 Building, 218 Xinghu SE DECISION MADE: 29-JAN-21
SuZhou CN 215000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DEX Device
Dex Surgical 510(k) NO: K191878(Traditional)
ATTN: Guillaume Noury PHONE NO : 33 1 69206969
3 Rue Des Petits Ruisseaux SE DECISION MADE: 29-JAN-21
Verrieres Le Buisson FR 91370 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: i_Space 1.5T Superconducting Magnetic Resonance Imaging System
MRI Division, Beijing Wandong Medi510(k) NO: K192650(Traditional)
ATTN: Zhou Lu PHONE NO : 86 10 65794660
No.7 Sanjianfang Nanli, Chaoyang DSE DECISION MADE: 29-JAN-21
Beijing CN 100024 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: R&D Series Nova Compo-B Plus Bottle, R&D Series Nova Compo-B Plus Single Dose
Imicryl Dis Malzemeleri Sanayi Ve 510(k) NO: K192913(Traditional)
ATTN: Muhammed Hulusi Sonmez PHONE NO : 90 542372 2723
Fetih Mahallesi Mahir Sokak No:5/2SE DECISION MADE: 19-JAN-21
Konya TR 42030 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Polyisoprene Powder Free, Black Colour Surgical Gloves
Emerson & Co. Srl 510(k) NO: K192933(Special)
ATTN: Laura Figliomeni PHONE NO : 39 0105 386400
Piazza Della Vittoria 10 SE DECISION MADE: 13-JAN-21
Genoa IT 16121 510(k) STATEMENT
DEVICE: ICE COMPRESSION FIRST, DUO, & MOOVE Systems
mks paris 510(k) NO: K193079(Traditional)
ATTN: Cervilla Stanislas PHONE NO : 0033 497642105
Zone Ecoparc 27 Rue Meziere SE DECISION MADE: 11-JAN-21
Fabregues FR 34690 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MIIN
Medico USA Inc. 510(k) NO: K193266(Traditional)
ATTN: Peter Son PHONE NO : 1 213 7031223
3407 W 6th St Suite 507 SE DECISION MADE: 22-JAN-21
Los Angeles CA 90020 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: uAI EasyTriage-Rib
Shanghai United Imaging Intelligen510(k) NO: K193271(Traditional)
ATTN: Zhao Xiaojing PHONE NO : 86 021 67076888
No. 199, Huanke Road SE DECISION MADE: 15-JAN-21
Shanghai CN 201210 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Insulin Syringe
Prominsemed Hangzhou Meditech Co.,510(k) NO: K193273(Traditional)
ATTN: Liqing Yang PHONE NO : 86 0571 88772985
No. 12, Longtan Road, Cangqian StrSE DECISION MADE: 05-JAN-21
Hangzhou CN 311121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Wrist Electronic Sphygmomanometer
Shenzhen Changkun Technology Co., 510(k) NO: K193386(Traditional)
ATTN: Steve Li PHONE NO : 86 0755 29100487
801, 3 Floor, 4 Floor, 5 Floor, 6 SE DECISION MADE: 27-JAN-21
Shenzhen CN 518118 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Arm Electronic Sphygmomanometer
ShenZhen Changkun Technology CO.,L510(k) NO: K193387(Traditional)
ATTN: Steve Li PHONE NO : 86 0755 29100487
801, 3 floor 4floor 5floor 6floor SE DECISION MADE: 27-JAN-21
Shenzhen CN 518118 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Fixone Biocomposite Interference Screw
AJU Pharm Co., Ltd. 510(k) NO: K193497(Traditional)
ATTN: Kim Joong Kil PHONE NO : 82 31 7654420
A-207, 697, Pangyo-ro SE DECISION MADE: 05-JAN-21
Seongnam-si KR 13511 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vivo 45 LS
Breas Medical AB 510(k) NO: K193586(Traditional)
ATTN: Ari Sobel PHONE NO : 617 3566289
Foretagsvagen 1 SE DECISION MADE: 27-JAN-21
Molnlyeke SE SE-453 33 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EBERLE Shaver System C3 and Accessories
Eberle GmbH & Co. KG 510(k) NO: K193608(Traditional)
ATTN: Udo Schniebs PHONE NO : 49 7044 96110
Glassbronnenstrasse 6 SE DECISION MADE: 15-JAN-21
Wurmberg DE 75449 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Applied Medical Anoscope
Applied Medical Resources 510(k) NO: K200021(Traditional)
ATTN: Frans VandenBroek PHONE NO : 949 7138369
22872 Avenida Empresa SE DECISION MADE: 06-JAN-21
Rancho Santa Margarita CA 92688 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Piccolo Medical SmartPICC System
Piccolo Medical, Inc 510(k) NO: K200037(Traditional)
ATTN: Alexey Salamini PHONE NO : 617 4071026
101 Mississippi St SE DECISION MADE: 22-JAN-21
San Fransico CA 94107 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Non-contact Infrared Body Thermometer, model:HTD8823US
HeTaiDa Technology Co., Ltd. 510(k) NO: K200159(Traditional)
ATTN: Tom Chen PHONE NO : 86 769 82658050
4F, BaiShiDa High-Tech Park, XiangSE DECISION MADE: 05-JAN-21
DongGuan City CN 523820 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ava Fertility Tracker
Ava AG 510(k) NO: K200163(Traditional)
ATTN: Blathnaid Feldman PHONE NO : 011 41 764431686
Gustrasse 73 SE DECISION MADE: 19-JAN-21
Zurich CH 8055 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Michler-Kapp Cardiovascular Vent Catheter
Kapp Surgical Instrument, Inc. 510(k) NO: K200289(Traditional)
ATTN: Nicole Merrifield PHONE NO : 216 5874400
4919 Warrensville Center Rd SE DECISION MADE: 28-JAN-21
Cleveland OH 44128 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ABI Instrument, Creo Electrosurgical System
Creo Medical Ltd. 510(k) NO: K200298(Traditional)
ATTN: Patrick Burn PHONE NO : 44 129 1643926
Creo House, Unit 2, Beaufort Park SE DECISION MADE: 05-JAN-21
Chepstow GB NP16 5UH 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BTL-703-2
BTL 510(k) NO: K200382(Traditional)
ATTN: David Chmel PHONE NO : 1 866 2851656
362 Elm Street SE DECISION MADE: 06-JAN-21
Marlborough MA 01752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HipXpert 3D Display and Anchoring Application
Surgical Planning Associates, Inc 510(k) NO: K200384(Traditional)
ATTN: Stephen B Murphy PHONE NO : 617 2774434
New England Baptist Hospital, 125 SE DECISION MADE: 28-JAN-21
Boston MA 02120 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BEE Cages
NGMedical GmbH 510(k) NO: K200429(Traditional)
ATTN: Stella Hahn PHONE NO : 49 06873 999970
Talsperrenblick 5 SE DECISION MADE: 29-JAN-21
Nonnweiler DE 66620 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Bfix Orthopedic External Fixator Systems
Aike (Shanghai) Medical Instrument510(k) NO: K200491(Traditional)
ATTN: Gu Hongying PHONE NO :
B320, B321, B322, B323, No. 1128, SE DECISION MADE: 05-JAN-21
Shanghai CN 201801 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: InBody
InBody Co. Ltd. 510(k) NO: K200560(Abbreviated)
ATTN: Koeun Jung PHONE NO : 82 02 5013939
InBody Bldg., 625, Eonju-ro, GangnSE DECISION MADE: 06-JAN-21
Seoul KR 06106 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Galapogos
ResMed Corp 510(k) NO: K200565(Traditional)
ATTN: Rose Malonzo PHONE NO : 858 8366727
9001 Spectrum Center Blvd SE DECISION MADE: 17-JAN-21
San Diego CA 92123 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENTity WiFi Video Nasopharyngoscope System
Optim, LLC 510(k) NO: K200609(Traditional)
ATTN: Jenna Lipka PHONE NO : 508 5565159
64 Technology Park Rd. SE DECISION MADE: 13-JAN-21
Sturbridge MA 01566 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EasyPath RF Introducer Sheath
Broncus Medical, Inc 510(k) NO: K200702(Traditional)
ATTN: Robin Bush PHONE NO : 650 4281600
125 Nicholson Lane SE DECISION MADE: 14-JAN-21
San Jose CA 95134 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CLEWICU System (ClewICUServer and ClewICUnitor)
CLEW Medical Ltd. 510(k) NO: K200717(Traditional)
ATTN: Avigdor Faians PHONE NO : 972 9 7795995
5 Hamelacha St. SE DECISION MADE: 09-JAN-21
Netanya IL 4206002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: pjur AQUA Baseline, pjur AQUA Guarana, pjur AQUA ProVitamin B5, pjur BACK DOOR anal Provitamin B5
pjur group Luxembourg SA 510(k) NO: K200731(Traditional)
ATTN: Andrea Giebel PHONE NO : 352 74 8989
87 esplanade de la Moselle SE DECISION MADE: 21-JAN-21
Wasserbillig LU L-6637 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Endoscope Valves Set, Disposable Endoscope Valves Set B
Wilson Instruments (SHA) Co., LTD 510(k) NO: K200769(Traditional)
ATTN: Juan Wu PHONE NO : 86 21 39290696 8027
Building 5, No. 258 Shuangbang Rd.SE DECISION MADE: 06-JAN-21
Shanghai CN 201702 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SurgiWrap FROST
MAST Biosurgery 510(k) NO: K200918(Traditional)
ATTN: Roel Trip PHONE NO : 858 5508050
6749 Top Gun St. Suite 108 SE DECISION MADE: 07-JAN-21
San Diego CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Altus Spine HA Pedicle Screw System
Altus Partners, LLC 510(k) NO: K200922(Special)
ATTN: Mark Melton PHONE NO : 610 3554156
1340 Enterprise Drive SE DECISION MADE: 26-JAN-21
West Chester PA 19380 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Halo Single-Loop Microsnare Kit
Argon Medical Devices, Inc. 510(k) NO: K200963(Traditional)
ATTN: Ana Jimenez-Hughes PHONE NO : 903 6764276
1445 Flat Creek Road SE DECISION MADE: 05-JAN-21
Athens TX 75751 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Thermidas IR System (ThIR-A615)
Thermidas Americas, Inc. 510(k) NO: K200999(Traditional)
ATTN: Karo Kujanpaa PHONE NO : 727 4602507
7912 Sailboat Key Blvd., Suite 508SE DECISION MADE: 06-JAN-21
South Pasadena FL 33707 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MyOnyx System
Thought Technology LTD. 510(k) NO: K201014(Traditional)
ATTN: Zena Butris PHONE NO : 1 514 4898251
5250 Ferrier, Suite 812 SE DECISION MADE: 13-JAN-21
Montreal CA H4P 1L3 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LUOFUCON PHMB Alginate Dressing (Rx use), LUOFUCON PHMB Antibacterial Alginate Wound Dressing (OTC use)
Huizhou Foryou Medical Devices Co.510(k) NO: K201016(Traditional)
ATTN: Guosheng Tan PHONE NO : 86 0752 5302185
No. 1 Shangxia North Road, DongjiaSE DECISION MADE: 28-JAN-21
Huizhou CN 516005 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENSEAL X1 Tissue Sealer, Curved Jaw, 25 cm Shaft Length, ENSEAL X1 Tissue Sealer, Curved Jaw, 37 cm Shaft Length, ENSEAL X1 Tissue Sealer, Curved Jaw, 45 cm Shaft Length
Ethicon Endo-Surgery, LLC 510(k) NO: K201066(Traditional)
ATTN: Nathan Anderson PHONE NO : 787 2726500
475 Calle C SE DECISION MADE: 22-JAN-21
Guaynabo PR 00969 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NeVa PV Thrombectomy Device
Vesalio 510(k) NO: K201085(Traditional)
ATTN: Gustavo Prado PHONE NO : 615 2067788
3200 West End Ave, Ste 500 SE DECISION MADE: 15-JAN-21
Nashville TN 37203 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Bidop 7
Koven Technology, Inc. 510(k) NO: K201114(Traditional)
ATTN: Heather Bell PHONE NO : 314 5422101
477 N. Lindbergh Blvd., Ste.220 SE DECISION MADE: 05-JAN-21
St. Louis MO 63141 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cytoplast Titanium-Reinforced PTFE Membranes
Osteogenics Biomedical, Inc. 510(k) NO: K201187(Traditional)
ATTN: Shane Shuttlesworth PHONE NO : 806 7961923
4620 71st St. Bldg. 78-79 SE DECISION MADE: 23-JAN-21
Lubbock TX 79424 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Biocore9 Femoral Head Resurfacing Component
BioCore9 LLC 510(k) NO: K201219(Traditional)
ATTN: Stan Matlak PHONE NO : 973 5854281
9 Whippany Road, BLDG A1, Unit 12 SE DECISION MADE: 19-JAN-21
Whippany NJ 07981 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Striate+™
Orthocell Ltd 510(k) NO: K201241(Traditional)
ATTN: Alison Carleton PHONE NO : 61 8936 02888
Building 191 Murdoch University, SSE DECISION MADE: 11-JAN-21
Perth AU 6150 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ORTHOLOC 2 with 3Di Technology Pilon Fracture Plating System
Wright Medical Technology, Inc. 510(k) NO: K201259(Traditional)
ATTN: Anna Hinton PHONE NO : 901 4516362
1023 Cherry Road SE DECISION MADE: 08-JAN-21
Memphis TN 38117 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Airway Mobilescope
Olympus Medical Systems Corp. 510(k) NO: K201300(Traditional)
ATTN: Toshiyuki Nakajima PHONE NO : 81 42 6422694
2951 Ishikawa-cho SE DECISION MADE: 26-JAN-21
Hachioji-Shi JP 192-8507 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Forwarts
Pronova Laboratories BV 510(k) NO: K201366(Traditional)
ATTN: Diede Klever PHONE NO : 31 2944 66611
Kruitpad 16 SE DECISION MADE: 21-JAN-21
Muiden NL 1398 CP 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Visage Breast Density
Visage Imaging GmbH 510(k) NO: K201411(Traditional)
ATTN: Stefan Strowich PHONE NO : 49 30 70096841
Lepsiusstrasse 70 SE DECISION MADE: 29-JAN-21
Berlin DE 12163 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sunset Heated CPAP Tube
Sunset Healthcare Solutions, Inc. 510(k) NO: K201418(Traditional)
ATTN: N. (Nazree) Williams PHONE NO : 312 9979980
180 N. Michigan Ave, Suite 2000 SE DECISION MADE: 29-JAN-21
Chicago IL 60601 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Pulse Oximeter
Shenzhen Creative Industry Co., Lt510(k) NO: K201468(Traditional)
ATTN: Jia Wang PHONE NO : 86 755264 33325
Floor 5, BLD 9 Baiwangxin High-TecSE DECISION MADE: 25-JAN-21
Shenzhen CN 518110 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: M-Vizion Femoral Revision System Extension
Medacta International SA 510(k) NO: K201471(Traditional)
ATTN: Stefano Baj PHONE NO : 41 91696 6060
Strada Regina SE DECISION MADE: 11-JAN-21
Castel San Pietro CH CH-6874 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Simply Iconic Implants
Implant Direct Sybron Manufacturin510(k) NO: K201553(Traditional)
ATTN: Reina Choi PHONE NO : 818 4443306
3050 East Hillcrest Drive SE DECISION MADE: 22-JAN-21
Thousand Oaks CA 91362 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MatriDerm
MedSkin Solutions Dr. Suwelack AG 510(k) NO: K201577(Traditional)
ATTN: Zuzana Hülsbusch PHONE NO : 0049 2543 2182202
Josef-Suwelack-Strasse 2 SE DECISION MADE: 07-JAN-21
Billerbeck DE 48727 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Infrared Thermometer
Shenzhen Xunwei Industrial Co., Lt510(k) NO: K201579(Traditional)
ATTN: Liu Shengcai PHONE NO : 86 755 86191210
First floor to fourth, Upper SmallSE DECISION MADE: 15-JAN-21
Shenzhen CN 518102 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Non-contact Electronic Forehead Infrared Thermometer
Zhongshan Jinli Electronic Weighin510(k) NO: K201582(Traditional)
ATTN: Jerry Liang PHONE NO : 86 0760 28133793
283rd South Min’an Road, Xiaolan TSE DECISION MADE: 15-JAN-21
Zhongshan CN 528416 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GenesisZr UHT700 Zirconia
United Dental Resources Corporatio510(k) NO: K201608(Traditional)
ATTN: John Von Thaden PHONE NO : 1 708 7465730
70 Towncenter Drive SE DECISION MADE: 28-JAN-21
University Park IL 60417 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Luna® G3 BPAP 25A
3B Medical, Inc. 510(k) NO: K201620(Traditional)
ATTN: Yasser Estafanous PHONE NO : 863 2266285
203 Avenue A NW, Suite 300 SE DECISION MADE: 29-JAN-21
Winter Haven FL 33881 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Medical Surgical Mask
Tianjin Saiyuan Technology CO., LT510(k) NO: K201625(Abbreviated)
ATTN: Hong Cai PHONE NO : 86 22 60406905
8 DongJiu Street, Zhongxin Road, PSE DECISION MADE: 12-JAN-21
Tianjin CN 300308 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VMCore Biopsy Needle
URO-1, Inc. 510(k) NO: K201650(Traditional)
ATTN: Thomas Lawson PHONE NO : 510 2061794
111 North Chestnut Street Suite 10SE DECISION MADE: 15-JAN-21
Winston Salem NC 27101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Potenza
Jeisys Medical, Inc. 510(k) NO: K201685(Traditional)
ATTN: Do Hyun Kim PHONE NO : 82 07 74354930
307, Daeryung Techno Town 8th, GamSE DECISION MADE: 19-JAN-21
Seoul KR 08501 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENSEAL X1 Tissue Sealer, Straight Jaw, 25 cm Shaft Length, ENSEAL X1 Tissue Sealer, Straight Jaw, 37 cm Shaft Length
Ethicon Endo-Surgery, LLC 510(k) NO: K201696(Traditional)
ATTN: Nathan Anderson PHONE NO : 787 2726500
475 Calle C SE DECISION MADE: 22-JAN-21
Guaynabo PR 00696 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BEGO Semados® RS/RSX Implant System
BEGO Implant Systems GmbH & Co. KG510(k) NO: K201700(Traditional)
ATTN: Bertrand Lecointe PHONE NO : 49 421 2028230
Wilhelm-Herbst-Str. 1 SE DECISION MADE: 13-JAN-21
Bremen DE 28359 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vital Sleep
The Snore Reliever Company, LLC 510(k) NO: K201719(Abbreviated)
ATTN: David Hernandez PHONE NO : 646 3160918
4201 Tonnelle Avenue; Unit 202 SE DECISION MADE: 14-JAN-21
North Bergen NJ 07047 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Pre-calibrated Suction
Brainlab AG 510(k) NO: K201752(Traditional)
ATTN: Chiara Cunico PHONE NO : 49 899 915680
Olof-Palme-Str. 9 SE DECISION MADE: 29-JAN-21
Munich DE 81829 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EVIS EXERA III Bronchovideoscope Olympus BF-XP190, EVIS EXERA III Bronchovideoscope Olympus BF-P190
Olympus Medical Systems Corp. 510(k) NO: K201758(Traditional)
ATTN: Toshiyuki Nakajima PHONE NO : 81 42 6422694
2951 Ishikawa-cho SE DECISION MADE: 21-JAN-21
Hachioji-Shi JP 192-8507 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: i-STAT TBI Plasma cartridge with the i-STAT Alinity System
Abbott Laboratories 510(k) NO: K201778(Traditional)
ATTN: Brian Ma PHONE NO : 609 4549360
400 College Road East SE DECISION MADE: 08-JAN-21
Princeton NJ 08540 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NuFace Trinity Plus Device
Carol Cole Company dba NuFACE 510(k) NO: K201782(Traditional)
ATTN: Danielle Barker Fernandes PHONE NO : 760 5091236
1325 Sycamore Avenue, Suite A SE DECISION MADE: 22-JAN-21
Vista CA 92081 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Rapid Acoustic Pulse Device
Soliton Inc. 510(k) NO: K201801(Traditional)
ATTN: Leslie Honda PHONE NO : 206 3758586
5304 Ashbrook Drive SE DECISION MADE: 29-JAN-21
Houston TX 77081 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Aquilion Lightning (TSX-036A/7) V10.2 with AiCE-i
Canon Medical Systems Corporation 510(k) NO: K201836(Traditional)
ATTN: Paul Biggins PHONE NO : 714 6697808
1385 Shimoishigami SE DECISION MADE: 12-JAN-21
Otawara-Shi JP 324-8550 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PediFlex Flexible Nail System
OrthoPediatrics Corp. 510(k) NO: K201838(Traditional)
ATTN: Yan Li PHONE NO : 574 2670864
2850 Frontier Drive SE DECISION MADE: 29-JAN-21
Warsaw IN 46582 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NeutrArt
Asset Medikal Tasarim AS. 510(k) NO: K201872(Traditional)
ATTN: Ebru Sirali PHONE NO : 902 124942727
Ikitelli OSB Mahallesi, 17. Cadde,SE DECISION MADE: 05-JAN-21
Istanbul TR 34490 510(k) STATEMENT
DEVICE: Sparrow Therapy System
Spark Biomedical, Inc. 510(k) NO: K201873(Traditional)
ATTN: Daniel Powell PHONE NO : 877 5467727
18208 Preston Road, Suite D9-531 SE DECISION MADE: 02-JAN-21
Dallas TX 75252 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sensor-Ureterorenoscope 9 FR WL 600 MM (short RIWO D-URS), Adapter For Controller 5525
Richard Wolf Medical Instruments C510(k) NO: K201897(Traditional)
ATTN: Michael Loiterman PHONE NO : 847 9131113
353 Corporate Woods Parkway SE DECISION MADE: 15-JAN-21
Vernon Hills IL 60061 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Trophikos Vaginal Moisturizer
Trophikos, LLC 510(k) NO: K201922(Traditional)
ATTN: Terri Jackson Wade PHONE NO : 404 7362595
1212 Collier Rd NW SE DECISION MADE: 14-JAN-21
Atlanta GA 30318 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nanum Syringe
Nanum Company Co., Ltd 510(k) NO: K201930(Traditional)
ATTN: Jeong Ung Jong PHONE NO : 82 53 7957076
4th floor, 40, Siji-ro SE DECISION MADE: 17-JAN-21
Daegu KR 42251 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: E-connect S Endo Motor with built-in Apex Locator
Changzhou Sifary Medical Technolog510(k) NO: K201993(Traditional)
ATTN: Amanda Zhu PHONE NO : 86 0519 85962691
No. 99, Qingyang Road, Xuejia CounSE DECISION MADE: 29-JAN-21
Changzhou City CN 213000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Passion Natural Water Based Lubricant
XR LLC 510(k) NO: K202017(Traditional)
ATTN: Louie Goryoka PHONE NO : 714 9071034
5251 Pipeline Lane SE DECISION MADE: 08-JAN-21
Huntington Beach CA 92649 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Maven Patient-Specific Instrumentation
Paragon 28, Inc. 510(k) NO: K202019(Traditional)
ATTN: Haylie Hertz PHONE NO : 303 7200017
14445 Grasslands Dr. SE DECISION MADE: 14-JAN-21
Englewood CO 80112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BioGuard EUS Air/Water and Suction Valves
Steris Corporation 510(k) NO: K202104(Traditional)
ATTN: Carroll Martin PHONE NO : 440 3586259
5976 Heisley Road SE DECISION MADE: 14-JAN-21
Mentor OH 44060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Medical Protective Mask
Guangdong Kingfa Sci.&Tech.Co., Lt510(k) NO: K202107(Traditional)
ATTN: Yu Xiaoge PHONE NO : 86 1357 0952157
28 Delong Avenue, Shijiao Town, QiSE DECISION MADE: 15-JAN-21
Qingyuan CN 511500 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Scorpion Stylet Portal Vein Access Set, Scorpion Needle Portal Vein Access Set
Argon Medical Devices, Inc. 510(k) NO: K202141(Traditional)
ATTN: Amy Clendening-Wheeler PHONE NO : 469 7311413
1445 Flat Creek Road SE DECISION MADE: 15-JAN-21
Athens TX 75751 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BTL-899ST
BTL 510(k) NO: K202199(Traditional)
ATTN: David Chmel PHONE NO : 1 866 2851656
362 Elm Street SE DECISION MADE: 26-JAN-21
Marlborough MA 01752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VX650
Luneau Technology Operations 510(k) NO: K202221(Traditional)
ATTN: Yossi Constantinis PHONE NO : 972 546 535299
2 rue Roger Bonnet SE DECISION MADE: 29-JAN-21
Pont-de-l'Arche FR 27340 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OBS Anchorage Screw, Biokey Anchorage Screw
Bomei Co, Ltd. 510(k) NO: K202278(Special)
ATTN: Steven Pan PHONE NO : 886 3 3554989
4F., No.1492-2, Chunrih Rd., TaoyuSE DECISION MADE: 08-JAN-21
Taoyuan City TW 33051 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Neodent Implant System - Zirconia Implant System
JJGC Industria e Comercio de Mater510(k) NO: K202282(Traditional)
ATTN: Mariana Soares Hartmann PHONE NO : 55 41 21694000
Av. Juscelino Kubitschek de OliveiSE DECISION MADE: 29-JAN-21
Curitiba BR 81270-200 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Button Loop
Yunyi (Beijing) Medical Device Co.510(k) NO: K202291(Traditional)
ATTN: Xiaowei Liu PHONE NO : 86 10 57234533
Floor 1-4, Building 4, No. 9 TianfSE DECISION MADE: 08-JAN-21
Beijing CN 102600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Wildcat PE Surgical Isolation Gown Open Back, Wildcat PE Surgical Isolation Gown Full Back
Wildcat PPE, LLC 510(k) NO: K202310(Traditional)
ATTN: Matthew McFarlane PHONE NO : 346 3674299
301 S. Trade Center Pkwy SE DECISION MADE: 29-JAN-21
Conroe TX 77385 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Procedure face mask (Model: KKF-2A)
Han Zhaoqing Sporting Goods Compan510(k) NO: K202314(Traditional)
ATTN: Zhang Ming PHONE NO : 86 138 25518595
NO.2-1, Kang tai Street, High-techSE DECISION MADE: 13-JAN-21
Zhaoqing CN 526238 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Lockado Repositionable Hemostasis Clip
Micro-Tech (Nanjing) Co., Ltd. 510(k) NO: K202333(Traditional)
ATTN: Sally He PHONE NO : 86 25 58646395
No.10 Gaoke Third Road SE DECISION MADE: 14-JAN-21
Nanjing CN 210032 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Patient Monitor
Edan Instruments, Inc. 510(k) NO: K202336(Traditional)
ATTN: Alice Yang PHONE NO : 86 755 26858736
#15 Jinhui Road, Jinsha Community,SE DECISION MADE: 23-JAN-21
Shenzhen CN 518122 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SR-1000 Portable DR Imaging System, SR-1000S Portable DR Imaging System
Shantou Institute of Ultrasonic In510(k) NO: K202350(Traditional)
ATTN: Flower Cai PHONE NO : 86 754 88250150
77 Jinsha Road SE DECISION MADE: 06-JAN-21
Shantou CN 515041 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Protective Face Mask for Medical Use
Hunan Heng Chang Pharmaceutical Co510(k) NO: K202358(Traditional)
ATTN: Tao Jingfeng PHONE NO : 86 0731 86670066
Floor 2,3, 102 of Building 16, StaSE DECISION MADE: 29-JAN-21
Changsha CN 410000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HBP7 Settable Hemostatic Bone Putty
Orthocon, Inc. 510(k) NO: K202363(Traditional)
ATTN: Howard Schrayer PHONE NO : 914 3572600
1 Bridge Street, Suite 121 SE DECISION MADE: 19-JAN-21
Irvington NY 10533 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAGIC Infusion Catheter
Balt USA, LLC 510(k) NO: K202366(Traditional)
ATTN: Corina Pierson PHONE NO : 949 7881443 770
29 Parker SE DECISION MADE: 29-JAN-21
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIR 800
Aesculap, Inc. 510(k) NO: K202391(Traditional)
ATTN: Kathy A. Racosky PHONE NO : 610 9849291
3773 Corporate Parkway SE DECISION MADE: 21-JAN-21
Center Valley PA 18034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ti3Z Cervical Interbody System
Zavation Medical Products, LLC 510(k) NO: K202398(Traditional)
ATTN: Katie Motley PHONE NO : 601 9191119
220 Lakeland Parkway SE DECISION MADE: 29-JAN-21
Flowood MS 39232 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BeneVision N12, BeneVision N15, BeneVision N17, BeneVision N19, BeneVision N22, BeneVision N1
Shenzhen Mindray Bio-medical Elect510(k) NO: K202405(Traditional)
ATTN: Yanhong Bai PHONE NO : 86 755 81888998
Mindray Building, Keji 12th Road SSE DECISION MADE: 07-JAN-21
Shenzhen CN 518057 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: cobas CTNG for use on cobas 6800/8800 systems
Roche Molecular Systems, Inc. 510(k) NO: K202408(Traditional)
ATTN: Aradhana Karthikeyan PHONE NO : 925 3537713
4300 Hacienda Drive SE DECISION MADE: 21-JAN-21
Pleasanton CA 94588-2722 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BrainInsight
Hyperfine Research, Inc 510(k) NO: K202414(Traditional)
ATTN: Robert Fasciano PHONE NO : 617 4359098
530 Old Whitfield St. SE DECISION MADE: 07-JAN-21
Guilford CT 06437 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VirtueRF
ShenB Co Ltd 510(k) NO: K202415(Traditional)
ATTN: Oskar Lee PHONE NO : 82 70 49122702
ShenB Bldg 148 Seongsui-ro SE DECISION MADE: 22-JAN-21
Seoul KR 04796 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZSFab Cervical Interbody System
ZSFab Inc. 510(k) NO: K202488(Traditional)
ATTN: Kai Xu PHONE NO : 213 8804966
705 Cambridge Street STE 1 SE DECISION MADE: 07-JAN-21
Cambridge MA 02141 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Surgical Face Mask
Jiangsu NewValue Medical Products 510(k) NO: K202491(Traditional)
ATTN: Zhou Zhengguo PHONE NO : 86 0523 86867878
Building G35, No. I Avenue, China SE DECISION MADE: 06-JAN-21
Taizhou CN 225300 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SIRION Lateral Lumbar Interbody Fusion
Astura Medical, LLC 510(k) NO: K202495(Traditional)
ATTN: Parker Kelch PHONE NO : 469 5015530
4949 W Royal Ln SE DECISION MADE: 06-JAN-21
Irving TX 75063 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GetSet Surgical GoPLF! Posterior Lateral Fusion System
GetSet Surgical, SA 510(k) NO: K202505(Traditional)
ATTN: Ole Stoklund PHONE NO : 41 79 2861486
Route de la Corniche 4 SE DECISION MADE: 11-JAN-21
Epalinges CH 1066 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EEA Circular Stapler with Tri-Staple Technology
Covidien 510(k) NO: K202507(Traditional)
ATTN: Leo Chen PHONE NO : 86 21 33230182
Rooms 501, 502, 601, 602 No.3 builSE DECISION MADE: 21-JAN-21
Min Hang District, Shanghai CN 20510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Standard Sterilizable Tray
Implant Direct Sybron Manufacturin510(k) NO: K202524(Traditional)
ATTN: Reina Choi PHONE NO : 818 3073132
3050 East Hillcrest Drive SE DECISION MADE: 28-JAN-21
Thousand Oaks CA 91362 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Instylla Delivery Kit
Instylla, Inc. 510(k) NO: K202544(Special)
ATTN: Jennifer Greer PHONE NO : 781 7904861
201 Burlington Rd, North Building SE DECISION MADE: 07-JAN-21
Bedford MA 01730 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ClearPoint Array System
ClearPoint Neuro, Inc. 510(k) NO: K202575(Traditional)
ATTN: Pete Piferi PHONE NO : 949 9006833
5 Musick SE DECISION MADE: 22-JAN-21
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Medical Surgical Mask-Model MP002-5, MP002-6
Jiangmen Sure&Me Medical Product C510(k) NO: K202577(Traditional)
ATTN: Liang Meixia PHONE NO : 86 181 38977291
Jingshuiwan, Chakeng Village CommiSE DECISION MADE: 11-JAN-21
Jiangmen CN 529000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Medical Surgical Masks-Non Sterile
Shandong T&F Nonwoven Co., LTD 510(k) NO: K202594(Traditional)
ATTN: Minsheng Zhao PHONE NO : 86 1800 5326009
South of Shuangyong Road, ChengyanSE DECISION MADE: 06-JAN-21
Qingdao CN 266100 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Premier Guard USA 3 Layer Ear Loop ASTM Level 3 Surgical Face Mask
Premier Guard USA LLC 510(k) NO: K202595(Traditional)
ATTN: Howard Sherman PHONE NO : 310 7177542
406 Briarwood Drive Suite 400 SE DECISION MADE: 21-JAN-21
Jackson MS 39206 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Halyard Lavender, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs and and Fentanyl Citrate
O & M Halyard, Inc. 510(k) NO: K202622(Abbreviated)
ATTN: Steven Dowdley PHONE NO : 678 4518062
1 Edison Drive SE DECISION MADE: 07-JAN-21
Alpharetta GA 30005 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Dentsply Sirona Universal Spray Glazes
Dentsply Sirona 510(k) NO: K202629(Traditional)
ATTN: Karl Nittinger PHONE NO : 717 8494424
221 West Philadelphia Street, SuitSE DECISION MADE: 20-JAN-21
York PA 17404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Surgical Mask
Jiangsu Medpure Biological Technol510(k) NO: K202640(Traditional)
ATTN: Jianwen Fei PHONE NO : 86 183 06118002
No. 1 Beiyang Road, Hexi Village, SE DECISION MADE: 22-JAN-21
ChangZhou CN 213144 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Gymform Total ABS
Well Brain International Ltd. 510(k) NO: K202653(Traditional)
ATTN: Victor K. Wai PHONE NO : 86 852 26190833
Room 1403 Fook Yip Building, 53-57SE DECISION MADE: 15-JAN-21
Hong Kong CN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPRINT PNS System
SPR Therapeutics, Inc. 510(k) NO: K202660(Traditional)
ATTN: Kathryn Stager PHONE NO : 216 3789108
22901 Millcreek Blvd. Suite 110 SE DECISION MADE: 22-JAN-21
Cleveland OH 44122 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Precision Delivery Infusion Set
Quest Medical, Inc. 510(k) NO: K202672(Traditional)
ATTN: Tosan Eweka PHONE NO : 972 3326338
One Allentown Parkway SE DECISION MADE: 21-JAN-21
Allen TX 75002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vycor Medical Viewsite Brain Access System (“VBAS”) and VBAS with Alignment Clip (“VBAS AC”) (together the “VBAS Family”)
Vycor Medical INC. 510(k) NO: K202694(Traditional)
ATTN: Theo Novak PHONE NO : 631 4634608
951 Broken Sound Parkway, STE 320 SE DECISION MADE: 14-JAN-21
Boca Raton FL 33487 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ART-Plan
TheraPanacea 510(k) NO: K202700(Traditional)
ATTN: Edwin Lindsay PHONE NO : 33 9 62527819
Pepiniere Cochin Paris Sante 29 RuSE DECISION MADE: 14-JAN-21
Paris FR 75014 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Medical Face Masks
Jiangxi Sanxin Medtec Co., Ltd. 510(k) NO: K202719(Traditional)
ATTN: Shuiqing Sun PHONE NO : 86 791 85988111
No. 999, Fushan Road, Xiaolan EconSE DECISION MADE: 04-JAN-21
Nanchang CN 330200 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Celerity 20 Steam Biological Indicator for IUSS
STERIS Corporation 510(k) NO: K202721(Traditional)
ATTN: Anthony Piotrkowski PHONE NO : 440 3927437
5976 Heisley Rd SE DECISION MADE: 08-JAN-21
Mentor OH 44060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Dolphin/IQ, Dolphin/4D and Dolphin/MAX with Dolphin/XF robot accessory
Viasonix Ltd. 510(k) NO: K202742(Traditional)
ATTN: Dan Manor PHONE NO : 972 9 7441692
10 Hamelacha Street SE DECISION MADE: 25-JAN-21
Raananna IL 4366105 510(k) STATEMENT
DEVICE: MasterScope, MasterScope CT, MasterScope ECG, MasterScope WSSU
eResearchTechnology GmbH 510(k) NO: K202754(Traditional)
ATTN: Margit Kohlen PHONE NO : 0049 93 0572060
Sieboldstrasse 3 SE DECISION MADE: 28-JAN-21
Estenfeld DE 97230 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vantage Orian 1.5T, MRT-1550, V6.0
Canon Medical Systems Corporation 510(k) NO: K202767(Traditional)
ATTN: Paul Biggins PHONE NO : 714 6697808
1385 Shimoishigami SE DECISION MADE: 15-JAN-21
Otawara-shi JP 324-8550 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VELYS™ Robotic-Assisted Solution
DePuy Ireland UC 510(k) NO: K202769(Traditional)
ATTN: Erin Combs PHONE NO : 574 3727211
Loughbeg SE DECISION MADE: 14-JAN-21
Ringaskiddy IE 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: iHealth Clinical Digital Thermometer
Andon Health Co., Ltd. 510(k) NO: K202791(Abbreviated)
ATTN: Liu Yi PHONE NO : 86 22 87611660 9223
No. 3 Jin Ping Street, Ya An Road,SE DECISION MADE: 05-JAN-21
Tianjin CN 300190 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BRIUS Clear Aligners
Brius Technologies, Inc 510(k) NO: K202792(Traditional)
ATTN: Kate Garrett PHONE NO :
2611 Westgrove Dr Ste 109 SE DECISION MADE: 22-JAN-21
Carrollton TX 75006 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AutoStrut G2
OrthoSpin Ltd 510(k) NO: K202810(Traditional)
ATTN: Oren Cohen PHONE NO : 972 54 3342651
13 Hayezira St. SE DECISION MADE: 06-JAN-21
Yokneam IL 2066720 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMMULITE® 2000 Cortisol
Siemens Healthcare Diagnostics Pro510(k) NO: K202826(Traditional)
ATTN: Malgorzata Robak PHONE NO : 0044 7921 882559
Glyn Rhonwy, Llanberis SE DECISION MADE: 15-JAN-21
Caernarfon GB LL55 4EL 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sequel External Fixation Device
Sequel Medical Inc. 510(k) NO: K202833(Traditional)
ATTN: Valentina Kamysheva PHONE NO : 305 8148299
12550 Biscayne Blvd Ste 110 SE DECISION MADE: 19-JAN-21
North Miami FL 33181-2536 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Overlapped Compression Therapy
JKH HEALTH CO., LTD. 510(k) NO: K202839(Traditional)
ATTN: Pu Jiang PHONE NO : 86 755 27926589
4-5F, Building 12, Hengmingzhu IndSE DECISION MADE: 21-JAN-21
Shenzhen CN 518104 510(k) STATEMENT
DEVICE: Surgical Face Masks (Sterile), Surgical Face Masks (Non-sterile)
B.J.ZH.F.Panther Medical Equipment510(k) NO: K202843(Traditional)
ATTN: Jiahui Li PHONE NO : 86 10 8078905861 07
Floor 3, Building 1, 28 Huoju StreSE DECISION MADE: 12-JAN-21
Beijing CN 102200 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Medical Surgical Gowns
Beijing Biosis Healing Biological 510(k) NO: K202844(Traditional)
ATTN: Ting Jiang PHONE NO : 86 10 61252030
No.6 plant west, Valley No.1 Bio-mSE DECISION MADE: 06-JAN-21
Beijing CN 102600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AccuBrain
BrainNow Medical Technology Limite510(k) NO: K202847(Traditional)
ATTN: Junbing Huang PHONE NO : 86 13 416183887
Unit 201, 2/F, Lakeside 2, No. 10 SE DECISION MADE: 15-JAN-21
Hong Kong CN 999077 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Diagnostic Ultrasound System, Models: Acclarix AX3, Acclarix AX3 Exp, Acclarix AX3 Super, Acclarix AX25, Acclarix AX28, Acclarix AX2, Acclarix AX2 Exp, Acclarix AX2 Super, Acclarix AX15, Acclarix AX18, Acclarix LX3, Acclarix LX3 Exp, Acclarix LX3 Super, Acclarix LX25 and Acclarix LX28
Edan Instruments, Inc. 510(k) NO: K202856(Traditional)
ATTN: Ying Dai PHONE NO : 86 15 221873029
#15 Jinhui Road, Jinsha Community,SE DECISION MADE: 25-JAN-21
Shenzhen CN 518122 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ClearPath Aligner
ClearPath Orthodontics Ltd 510(k) NO: K202857(Traditional)
ATTN: Waqas Wahab PHONE NO : 92 42 111333276
6-N, Main Boulevard SE DECISION MADE: 05-JAN-21
Johar Town PK 54000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Flex-ThreadTM Distal Fibula Intramedullary Nail System
Conventus Orthopaedics, LLC 510(k) NO: K202858(Traditional)
ATTN: Amanda Pentecost PHONE NO : 215 3234029
10200 73rd Ave N. Suite 122 SE DECISION MADE: 22-JAN-21
Maple Grove MN 55369 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Puritan Bennett Cuff Pressure Manager
Covidien llc 510(k) NO: K202874(Traditional)
ATTN: Jenny Liu PHONE NO : 86 21 33230131
6F, Building 3, 2388 Chenhang RoadSE DECISION MADE: 09-JAN-21
Shanghai CN 201114 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Prase-AP Anterior Cervical Plate System
GBS Commonwealth Co., Ltd. 510(k) NO: K202878(Traditional)
ATTN: Jimmy Kim PHONE NO : 82 2 69254469
C-309, Woolim Lion's Valley, 168, SE DECISION MADE: 29-JAN-21
Geumcheon-gu KR 08507 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: J-Plasma Precise FLEX Handpiece
Apyx Medical Corporation (formerly510(k) NO: K202880(Traditional)
ATTN: Lauren Tiller PHONE NO : 727 8038550
5115 Ulmerton Road SE DECISION MADE: 04-JAN-21
Clearwater FL 33760-4004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vital Signs Monitor:iM3s, iM3As, iM3Bs, iHM3s
Edan Instruments, Inc. 510(k) NO: K202892(Traditional)
ATTN: Alice Yang PHONE NO : 86 75 526858736
#15 Jinhui Road, jinsha Community,SE DECISION MADE: 28-JAN-21
Shenzhen CN 518122 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Surgical Face Mask
Jiangxi Feilikang Medical Technolo510(k) NO: K202904(Traditional)
ATTN: Shijun Zhang PHONE NO : 86 799 2181777
Building 8, Anyuan Electronic InfoSE DECISION MADE: 21-JAN-21
Pingxiang CN 337000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Blood Pressure Monitor
Bioland Technology Ltd. 510(k) NO: K202934(Traditional)
ATTN: Yiqing Feng PHONE NO : 86 755 36900999
No. A6B7 (Block G), ShangRong InduSE DECISION MADE: 26-JAN-21
Shenzhen CN 518116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ventway Sparrow
Inovytech Medical Solutions Ltd. 510(k) NO: K202970(Traditional)
ATTN: Dana Hofeller PHONE NO : 972 9 7794134
3 Hanagar Street SE DECISION MADE: 29-JAN-21
Hod Hasharon Tel-Aviv IL 4501306 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Platinum dRF Imaging System
Apelem-DMS Group 510(k) NO: K203010(Special)
ATTN: Samuel Sancerni PHONE NO : 330 467504900
Parc Scientifique Georges Besse 17SE DECISION MADE: 22-JAN-21
Nimes FR 30005 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IBM iConnect Access
Merge Healthcare Incorporated 510(k) NO: K203104(Traditional)
ATTN: Carol Nakagawa PHONE NO : 905 3162579
900 Walnut Ridge Drive SE DECISION MADE: 26-JAN-21
Hartland WI 53029 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Inion CompressOn Screw
Inion Oy 510(k) NO: K203105(Traditional)
ATTN: Kati Marttinen PHONE NO : 358 10 8306600
Laakarinkatu 2 SE DECISION MADE: 13-JAN-21
Tampere FI 33520 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LOGIQ P10, LOGIQ P9, LOGIQ P8
GE Medical Systems Ultrasound and 510(k) NO: K203114(Traditional)
ATTN: Bryan Behn PHONE NO : 262 2475502
,LLC 9900 Innovation Dr. SE DECISION MADE: 08-JAN-21
Wauwatosa WI 53226 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TissueTak device
Via Surgical Ltd. 510(k) NO: K203117(Traditional)
ATTN: Ofek Levin PHONE NO : 972 52 6395765
Mitzpe Kineret Street 22/1 SE DECISION MADE: 07-JAN-21
Amirim IL 2011500 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) System
Precision Spine, Inc. 510(k) NO: K203129(Traditional)
ATTN: Michael Dawson PHONE NO : 601 4204244
2050 Executive Drive SE DECISION MADE: 12-JAN-21
Pearl MS 39208 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EV1000 Clinical Platform Non-Invasive (NI) or ClearSight System, EV1000 Clinical Platform
Edwards Lifesciences, LLC 510(k) NO: K203131(Traditional)
ATTN: Christine Chun PHONE NO : 949 2502773
One Edwards Way SE DECISION MADE: 22-JAN-21
Irvine CA 92614 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Veuron-Brain-pAb
Heuron Co., Ltd. 510(k) NO: K203142(Traditional)
ATTN: Dong Hoon Shin PHONE NO : 82 32 4298508
10th Floor, 7, Mirae-ro, Namdong-gSE DECISION MADE: 15-JAN-21
lncheon KR 21558 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CREO Stabilization System, Navigation Instruments, ExcelsiusGPS
Globus Medical Inc. 510(k) NO: K203153(Traditional)
ATTN: Jennifer Antonacci PHONE NO : 610 9301800 1861
2560 General Armstead Ave. SE DECISION MADE: 19-JAN-21
Audubon PA 19403 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nerivio, FGD000075-4.7
Theranica Bioelectronics ltd 510(k) NO: K203181(Traditional)
ATTN: Alon Ironi PHONE NO : 972 72 3909763
4 Ha-Omanutst. Poleg Industrial PaSE DECISION MADE: 22-JAN-21
Netanya IL 4250574 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AEROCURE-MD
Aerobiotix, Inc. 510(k) NO: K203189(Third Party - Traditional)
ATTN: David Kirschman PHONE NO : 888 9787087
444 Alexandersville Rd. SE DECISION MADE: 21-JAN-21
Miamisburg OH 45342 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL Interfixated System, Brigade Hyperlordotic System, Brigade Standalone System, Brigade Lateral System, BASE Interfixated Titanium System, Coalesce Thoracolumbar Interbody Fusion System, Cohere Thoracolumbar Interbody System, Modulus XLIF Interbody System, Modulus TLIF Interbody System, Modulus ALIF System
NuVasive, Incorporated 510(k) NO: K203201(Traditional)
ATTN: Sali Gully PHONE NO : 858 4582285
7475 Lusk Blvd. SE DECISION MADE: 12-JAN-21
San Diego CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AirPhysio Positive Expiratory (PEP) Device
AirPhysio Pty Ltd 510(k) NO: K203209(Third Party - Traditional)
ATTN: Paul O’Brien PHONE NO : 61 7 35350640
Unit 1, 43 Greenway Drive SE DECISION MADE: 15-JAN-21
Tweed Heads South AU NSW 2486 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: cobas BKV
Roche Molecular Systems, Inc. 510(k) NO: K203220(Traditional)
ATTN: Raji Grewal PHONE NO : 925 3680246
4300 Hacienda Drive SE DECISION MADE: 29-JAN-21
Pleasanton CA 94588-2722 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Reliance EPS Endoscope Processing System and Reliance DG Dry Germicide
STERIS 510(k) NO: K203223(Traditional)
ATTN: Marcia L. Benedict PHONE NO : 440 3927063
5960 Heisley Rd SE DECISION MADE: 28-JAN-21
Mentor OH 44060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Switched Internal Paddles
Philips North America LLC 510(k) NO: K203231(Special)
ATTN: Neha Hardiya PHONE NO : 425 9082569
22100 Bothell Everett Hwy SE DECISION MADE: 11-JAN-21
Bothell WA 98021 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OmniGuide BeamPath OTO-U Fiber
OmniGuide, Inc. 510(k) NO: K203241(Special)
ATTN: David Johnson PHONE NO : 617 5518410
4 Maguire Road SE DECISION MADE: 14-JAN-21
Lexington MA 02421 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMMULITE/IMMULITE® 1000 Cortisol
Siemens Healthcare Diagnostics Pro510(k) NO: K203270(Traditional)
ATTN: Malgorzata Robak PHONE NO : 0044 7921 882559
Glyn Rhonwy SE DECISION MADE: 15-JAN-21
Llanberis GB LL55 4EL 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Hepatica v1 (Hepatica v1.0.0)
Perspectum Ltd. 510(k) NO: K203280(Traditional)
ATTN: Jaco Jacobs PHONE NO : 44 0 1865655329
5520 John Smith Drive SE DECISION MADE: 12-JAN-21
Oxford GB OX4 2LL 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ali Interbody Fusion System
Raed M. Ali, M.D., Inc. 510(k) NO: K203308(Special)
ATTN: Raed Ali PHONE NO : 714 4743367
6 Starcatcher Circle SE DECISION MADE: 15-JAN-21
Newport Coast CA 92657 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VERTACONNECT TLIF Cage
SIGNUS Medizintechnik 510(k) NO: K203327(Traditional)
ATTN: Antje Schmidt PHONE NO : 49 6023 9166
Industriestrasse 2 SE DECISION MADE: 25-JAN-21
Alzenau DE 63755 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HeartFlow Analysis
HeartFlow, Inc. 510(k) NO: K203329(Traditional)
ATTN: Windi Hary PHONE NO : 415 5313435
1400 Seaport Boulevard, Building BSE DECISION MADE: 08-JAN-21
Redwood City CA 94063 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEOLab Clear Aligners
New England Ortho Lab, Inc 510(k) NO: K203339(Special)
ATTN: Christian Saurman PHONE NO : 800 9226365 123
3 Riverside Drive SE DECISION MADE: 06-JAN-21
Andover MA 01810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MULTIX Impact C
Siemens Medical Solutions USA, Inc510(k) NO: K203340(Traditional)
ATTN: Martin Rajchel PHONE NO : 484 4734209
40 Liberty Blvd Mail code: 65-1A SE DECISION MADE: 06-JAN-21
Malvern PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACS LD Uni FB Knee System
Implantcast GmbH 510(k) NO: K203341(Traditional)
ATTN: Juliane Hoeppner PHONE NO : 00049 4161 744135
Lueneburger Schanze 26 SE DECISION MADE: 08-JAN-21
Buxtehude DE 21614 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MULTIX Impact
Siemens Medical Solutions USA, Inc510(k) NO: K203345(Traditional)
ATTN: Martin Rajchel PHONE NO : 484 4734209
40 Liberty Blvd Mail code: 65-1A SE DECISION MADE: 07-JAN-21
Malvern PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Advanced Research Medical Trident SI Screw System
Advanced Research Medical, LLC 510(k) NO: K203373(Traditional)
ATTN: John D. Siegel PHONE NO : 610 4575324
1515 Hwy 13 East SE DECISION MADE: 22-JAN-21
Burnsville MN 55337 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Dynanail Mini Hybrid
MedShape Inc 510(k) NO: K203381(Traditional)
ATTN: Akhilesh Gokhale PHONE NO : 678 2353311
1575 Northside Drive, Suite 440 SE DECISION MADE: 15-JAN-21
Atlanta GA 30318 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Marrow-Pack (white)- 11gauge/10cm or 13gauge/10cm, Marrow-Tray (red)- 11gauge/10cm or 13gauge/10cm, Marrow-Set (violet)- 11gauge/10cm or 13gauge/10cm, Marrow-kit (grey)- 11gauge/10cm or 13gauge/10cm, Marrow-Stem (green)- 11gauge/10cm or 13gauge/10cm
Biopsybell s.r.l. 510(k) NO: K203397(Traditional)
ATTN: Carlo Ricca Prandi Bellini PHONE NO : 39 0535 27850
Via A. Manuzio, 24 SE DECISION MADE: 11-JAN-21
Mirandola IT 41037 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EVOS Large Fragment Plating System
Smith & Nephew, Inc. 510(k) NO: K203405(Traditional)
ATTN: Thomas Fearnley PHONE NO : 901 3991224
1450 E Brooks Rd SE DECISION MADE: 27-JAN-21
Memphis TN 38116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD Hypodermic Syringe
Becton Dickinson and Company 510(k) NO: K203453(Traditional)
ATTN: Charlton Foo PHONE NO : 1 857 2701395
1 Becton Drive SE DECISION MADE: 25-JAN-21
Franklin Lakes NJ 07417 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OSSIOfiber Cannulated Trimmable Fixation Nail, OSSIOfiber Trimmable Fixation Nail, OSSIOfiber Trimmable Fixation Nail, Cannulated Design
OSSIO Ltd. 510(k) NO: K203465(Traditional)
ATTN: Taly Lindner PHONE NO : 972 4 9986600
8 HaTochen St. SE DECISION MADE: 06-JAN-21
Caesarea IL 3079861 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Biomet Microfixation RibFix Advantage System
Biomet Micofixation 510(k) NO: K203474(Traditional)
ATTN: Lauren Jasper PHONE NO : 904 7419259
1520 Tradeport Drive SE DECISION MADE: 28-JAN-21
Jacksonville FL 32218 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: M.U.S.T. Pedicle Screw Extension and Long Tab Implants
Medacta International SA 510(k) NO: K203482(Traditional)
ATTN: Stefano Baj PHONE NO : 41 91 6966060
Strada Regina SE DECISION MADE: 26-JAN-21
Castel San Pietro CH CH-6874 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SnugFit All-Suture Anchor
Medacta International SA 510(k) NO: K203485(Traditional)
ATTN: Stefano Baj PHONE NO : 41 91 6966060
Strada Regina SE DECISION MADE: 19-JAN-21
Castel San Pietro CH CH-6874 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PERLA® TL posterior osteosynthesis system
SPINEART 510(k) NO: K203506(Traditional)
ATTN: Franck Pennesi PHONE NO : 41 22 5701200
3 chemin du pré Fleuri SE DECISION MADE: 15-JAN-21
Plan Les Ouates CH 1228 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vitality® Spinal Fixation System
Zimmer Biomet Spine, Inc. 510(k) NO: K203507(Traditional)
ATTN: Alex Pawlowski PHONE NO : 303 2648255
10225 Westmoor Drive SE DECISION MADE: 28-JAN-21
Westminster CO 80021 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: C Scope Visualization System
CIT Ortho 510(k) NO: K203526(Third Party - Traditional)
ATTN: Megan Lecavalier PHONE NO : 440 7721421
26202 Detroit Road Ste 340 SE DECISION MADE: 12-JAN-21
Westlake OH 44145 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: XYPAN Expandable Lumbar Cage System
Aegis Spine, Inc. 510(k) NO: K203531(Traditional)
ATTN: Woo Joong Kwon PHONE NO :
9781 S. Meridian Blvd, Ste 300 SE DECISION MADE: 29-JAN-21
Englewood CO 80112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ChoiceSpine Navigation System
ChoiceSpine, LLC 510(k) NO: K203561(Special)
ATTN: Kim Finch PHONE NO : 865 2433969
400 Erin Drive SE DECISION MADE: 04-JAN-21
Knoxville TN 37919 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BioGuard Air/Water and Suction Valves
STERIS Corporations 510(k) NO: K203630(Special)
ATTN: Carroll Martin PHONE NO : 440 3586259
5976 Heisley Road SE DECISION MADE: 08-JAN-21
Mentor OH 44060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: StealthStation Cranial Software v1.3.2
Medtronic Navigation, Inc. 510(k) NO: K203639(Special)
ATTN: Taylor Gold West PHONE NO : 720 8902322
826 Coal Creek Circle SE DECISION MADE: 13-JAN-21
Louisville CO 80027 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Blood Pressure Cuff, U1883S,U1883D, U1882S, U1882D, U1881S, U1881D, Blood Pressure Cuff, U1885S, U1885D, U1880S, U1880D, U1886S, U1886D, Blood Pressure Cuff, U1869S, U1869D, U1889S, U1889D, U1884S, U1884D, Blood Pressure Cuff, U1710S, U1720S, U1730S,U1740S, U1750S, U1760S, Blood Pressure Cuff, U1770S, U1790s, U1710D, U1720D, U1730D, U1740D
JKH USA, LLC 510(k) NO: K203652(Traditional)
ATTN: Bill Quanqin Dai PHONE NO : 909 9299896
20505 Valley Blvd. Suite 108 SE DECISION MADE: 06-JAN-21
Walnut CA 91789 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Non-Contact Forehead Thermometer (UT30H)
Uni-Trend Technology(CHINA) CO.,LT510(k) NO: K203656(Third Party - Traditional)
ATTN: Mike Mao PHONE NO : 86 769 85723888
No 6, Gong Ye Bei 1st Road, SongshSE DECISION MADE: 22-JAN-21
Dongguan CN 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: Micro C Medical Imaging System, M01
OXOS Medical, Inc. 510(k) NO: K203658(Third Party - Traditional)
ATTN: Evan Ruff PHONE NO : 855 7339729
1230 Peachtree Street NE Suite 300SE DECISION MADE: 12-JAN-21
Atlanta GA 30309 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: Mobius3D
Varian Medical Systems, Inc. 510(k) NO: K203669(Special)
ATTN: Peter J. Coronado PHONE NO : 650 4246320
3100 Hansen Way SE DECISION MADE: 14-JAN-21
Palo Alto CA 94304 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System
Medacta International SA 510(k) NO: K203671(Special)
ATTN: Stefano Baj PHONE NO : 41 91 6966060
Strada Regina SE DECISION MADE: 13-JAN-21
Castel San Pietro CH CH-6874 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ViewPoint 6
GE Medical Systems Ultrasound & Pr510(k) NO: K203677(Special)
ATTN: Tracey Ortiz PHONE NO : 262 4701003
9900 W. Innovation Drive SE DECISION MADE: 15-JAN-21
Wauwatosa WI 53226 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CD HORIZON™ Spinal System
Medtronic Sofamor Danek USA, INC. 510(k) NO: K203678(Special)
ATTN: Madhuvanthi Soundirarajan PHONE NO : 901 3963133
1800 Pyramid Place SE DECISION MADE: 15-JAN-21
Memphis TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CarboClear Lumbar Cage System
CarboFix Orthpedics Ltd. 510(k) NO: K203683(Special)
ATTN: Hila Wachsler-Avrahami PHONE NO : 972 9 9511511
11 Ha'Hoshlim Street SE DECISION MADE: 15-JAN-21
Herzeliya IL 4672411 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IntraSight Mobile
Volcano Corporation 510(k) NO: K203719(Special)
ATTN: Linda Schulz PHONE NO : 425 9081362
3721 Valley Centre Dr Ste 500 SE DECISION MADE: 19-JAN-21
San Diego CA 92130 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACUSON AcuNav Volume Intracardiac Echocardiography(ICE) Catheter
Siemens Medical Solutions USA, Inc510(k) NO: K203726(Special)
ATTN: HyunJung Lee PHONE NO : 425 2815061
22010 S.E. 51st Street SE DECISION MADE: 19-JAN-21
Issaquah WA 98029 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Non-Contact Forehead Thermometer (Models UT306H & UT308H)
Uni-Trend Technology (China) Co., 510(k) NO: K203747(Third Party - Traditional)
ATTN: Mike Mao PHONE NO : 86 769 85723888
No 6, Gong Ye Bei 1st Road, SongshSE DECISION MADE: 25-JAN-21
Guangzhou CN 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: vatech A9 (Model : PHT-30CSS)
Vatech Co., Ltd 510(k) NO: K203797(Special)
ATTN: Daniel Kim PHONE NO : 82 31 3799492
13, Samsung 1-ro 2-gil SE DECISION MADE: 25-JAN-21
Hwaseong-si KR 18449 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VASOBand Vascular Compression Device
VASOInnovations, Inc 510(k) NO: K203803(Third Party - Traditional)
ATTN: Rajendra Gurudas Sardesai PHONE NO : 626 6882568
1260 Huntington Drive Suite 208 SE DECISION MADE: 26-JAN-21
South Pasadena CA 91030 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: BOSS 8F Balloon Guide Catheter
Marblehead Medical LLC 510(k) NO: K203840(Special)
ATTN: Kristin M. Mortenson PHONE NO : 612 2021142
753 Fox Chase Rd SW SE DECISION MADE: 28-JAN-21
Rochester MN MN 55902-8749 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: General Radiography CXDI-CS01
CANON INC. 510(k) NO: K203849(Special)
ATTN: Akira Hirai PHONE NO : 81 33 7582111
9-1 Imaikami-Cho, Nakahara-Ku SE DECISION MADE: 26-JAN-21
Kawasaki JP 211-8501 510(k) SUMMARY AVAILABLE FROM FDA
TOTAL 510(k)s THIS PERIOD 200
TOTAL WITH SUMMARIES 196
TOTAL WITH STATEMENTS 4
