510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD April 2023
DEVICE: AUTION MAX AX-4060 Urinalysis System
Arkray Inc. 510(k) NO: K193514(Traditional)
ATTN: Hideko Kosaka PHONE NO : 81 5058 301004
Yousuien-Nai, 59 Gansuin-Cho SE DECISION MADE: 13-APR-23
Kamigyo-ku JP 602-0008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Inomax DSIR
Mallinckrodt Manufacturing LLC 510(k) NO: K211153(Traditional)
ATTN: David Trueblood PHONE NO : 608 3953910
6603 Femrite Drive SE DECISION MADE: 20-APR-23
Madison WI 53718 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: N2
MegaGen Implant Co., Ltd. 510(k) NO: K211556(Traditional)
ATTN: Jae Ho Lee PHONE NO : 82 53 2472266
45, Secheon-ro,7-gil SE DECISION MADE: 05-APR-23
Daegu KR 42921 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Selux AST System; Model AST Gen 1.0
Selux Diagnostics, Inc 510(k) NO: K211748(Traditional)
ATTN: Eric Stern PHONE NO :
56 Roland St, Suite 206 SE DECISION MADE: 19-APR-23
Charlestown MA 02129 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ArtFX Spinal Fixation System
ArtFX Medical LLC 510(k) NO: K212220(Traditional)
ATTN: Ozgen Ozfidan PHONE NO : 1 917 4452028
50 Laura St #2524 SE DECISION MADE: 20-APR-23
Jacksonville FL 32202 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Myolift QT
Johari Digital Healthcare Limited 510(k) NO: K213078(Traditional)
ATTN: Pooja Johari PHONE NO : 818 5218947
G-582, 584 EPIP, Boranda SE DECISION MADE: 27-APR-23
Jodhpur IN 342012 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SENSOSEEG Depth Electrodes
Sensomedical Labs LTD 510(k) NO: K213170(Traditional)
ATTN: Sama Tarazi PHONE NO : 972 545447743
Nazareth Industrtial Park SE DECISION MADE: 18-APR-23
Nazareth IL 1612102 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Reprocessed NRG Transseptal Needle
Innovative Health, LLC. 510(k) NO: K213584(Traditional)
ATTN: Rick Ferreira PHONE NO : 877 4003740
1435 North Hayden Road, Suite 100 SE DECISION MADE: 04-APR-23
Scottsdale AZ 85257 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Masimo Rad-G with Temperature
Masimo Corporation 510(k) NO: K213676(Traditional)
ATTN: Sahar Bagheri PHONE NO : 949 2977518
52 Discovery SE DECISION MADE: 16-APR-23
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: G7, Dental Operative Unit and Accessories
Shinhung Company Ltd 510(k) NO: K213749(Traditional)
ATTN: Sam Su Kyong PHONE NO : 82 2 63662175
Shinhung Bldg, 450 Cheongpa-ro, JuSE DECISION MADE: 03-APR-23
Seoul KR 100-858 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Oxygen Concentrator model 8F-3A, Oxygen Concentrator model 8F-5A
Jiangsu Yuyue Medical Equipment & 510(k) NO: K213825(Traditional)
ATTN: Wei Yan PHONE NO : 0086 511 86900833
No. 1 Baisheng Road, Development ZSE DECISION MADE: 28-APR-23
Danyang CN 212300 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CerebralGo Plus
Yukun (Beijing) Technology Co., Lt510(k) NO: K213986(Traditional)
ATTN: Wang Qi PHONE NO : 86 10 89735152
Room 313/315, Building 3, No.11 ChSE DECISION MADE: 13-APR-23
Beijing CN 102200 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: D·Kaptain PTA High Pressure Balloon Dilatation Catheter
DK Medical Technology Co., Ltd. 510(k) NO: K214009(Traditional)
ATTN: Shi Quan PHONE NO : 86 182 60139686
301 unit, bioBAY B1, 218 Xinghu StSE DECISION MADE: 05-APR-23
Suzhou CN 215123 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BRM Digitalis Spacer
BRM Extremities Srl 510(k) NO: K220142(Traditional)
ATTN: Andrea De Maglio PHONE NO : 389 193 8034
Via Papa Giovanni XXIII, 9 SE DECISION MADE: 04-APR-23
Civate IT 23862 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEST-C Interbody System
Paonan Biotech Co., Ltd. 510(k) NO: K220261(Traditional)
ATTN: Penny Huang PHONE NO : 886 2 26274366
3F, No.50, Lane 258, Rueiguang RoaSE DECISION MADE: 24-APR-23
Taipei City TW 114062 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Kisar Stratford SI Screw System
Anjali Investments L.L.C 510(k) NO: K220274(Traditional)
ATTN: Amit Patel PHONE NO : 478 7144604
1901 Cranbourne Rd SE DECISION MADE: 24-APR-23
Lutherville MD 21093 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NP Medical nPulse K150 Neutral Displacement Needle Free Connector, nPulse Neutral displacement needle free connector, nPulse K150 Needle Free Connector
NP Medical Inc 510(k) NO: K220288(Traditional)
ATTN: Krishna Govindarajan PHONE NO : 484 3541755
101 Union Street SE DECISION MADE: 19-APR-23
Clinton MA 01510 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Polyfusion IV Administration Sets
Poly Medicure Limited 510(k) NO: K220312(Traditional)
ATTN: Ramdas Sharma PHONE NO : 91 98733 80144
Plot No. PA 010-018, 010-019, MahiSE DECISION MADE: 12-APR-23
Jaipur IN 302237 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STERLINK mini Sterilizer with STERLOAD mini Cassette, Tyvek Roll with CI for STERLINK Sterilizer, Sterilization Process Indicator for STERLINK Sterilizer; Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-Bio), Terragene Chemdye (CD42), Terragene Cintape (CT40)
Plasmapp Co., Ltd. 510(k) NO: K220345(Traditional)
ATTN: Seung Hun Lee PHONE NO : 82 042 7162115
BVC-111, 125, Gwahak-ro, Yuseong-gSE DECISION MADE: 14-APR-23
Daejeon KR 34141 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vivally System Wearable, Non-Invasive Neuromodulation System and Mobile Application
Avation Medical, Inc. 510(k) NO: K220454(Traditional)
ATTN: Manish Vaishya PHONE NO : 614 5914201
1375 Perry St SE DECISION MADE: 03-APR-23
Columbus OH 43201 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Elecsys FT4 IV
Roche Diagnostics 510(k) NO: K220456(Traditional)
ATTN: Bin Sun PHONE NO : 317 2923781
9115 Hague Road SE DECISION MADE: 07-APR-23
Indianapolis IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NITRO Interbody Fusion Cage System Family
CTL Medical Corporation 510(k) NO: K220513(Traditional)
ATTN: Sean Suh PHONE NO : 214 5455820
4550 Excel Parkway SE DECISION MADE: 25-APR-23
Addison TX 75001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Kurin Blood Culture Collection Set with Kurin Lock Technology
Kurin, Inc, 510(k) NO: K220677(Traditional)
ATTN: Neal Hartman PHONE NO : 888 9639056
10840 Thornmint Road, Suite 111 SE DECISION MADE: 28-APR-23
San Diego CA 920127 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALPCO Calprotectin Immunoturbidimetric Assay
ALPCO 510(k) NO: K220763(Traditional)
ATTN: Chris Wisherd PHONE NO : 800 5925726 221
26-G Keewaydin Drive SE DECISION MADE: 13-APR-23
Salem NH 03079 510(k) STATEMENT
DEVICE: TrachCuff Cuff Controller
AW Technologies ApS 510(k) NO: K220854(Traditional)
ATTN: Adam Hansen PHONE NO : 45 54 261827
Amalienborgvej 57 SE DECISION MADE: 14-APR-23
Noerresundby DK DK-9700 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SUPERPLAST Double-Occluder, SUPERPLAST Vascular Probe
Fehling Surgical Instruments, Inc.510(k) NO: K220981(Traditional)
ATTN: Hayden Hosch PHONE NO : 1 800 3345464
1690 Stone Village Lane STE 721 SE DECISION MADE: 20-APR-23
Kennesaw GA 30152 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Renova RP Centesis Pump
GI Supply, Inc. 510(k) NO: K221042(Traditional)
ATTN: Erika Parry PHONE NO : 607 4252271
5069 Ritter Road Suite 104 SE DECISION MADE: 19-APR-23
Mechanicsburg PA 17055 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CO2 Mainstream Sensor
Draegerwerk AG & Co. KGaA 510(k) NO: K221118(Traditional)
ATTN: Lyubov Lange PHONE NO : 494 518 823247
53/55 Moislinger Allee SE DECISION MADE: 05-APR-23
Luebeck DE 23542 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Kyphoplasty Balloon System
OK MediNet Korea Co., Ltd. 510(k) NO: K221142(Traditional)
ATTN: Kang Yoo Jin PHONE NO : 82 2 8334489
418, 415 Namsung Plaza, 130, DigitSE DECISION MADE: 21-APR-23
Seoul KR 08589 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Montross Extremity Medical Hemi Implant System
Montross Extremity Medical 510(k) NO: K221220(Traditional)
ATTN: William Montross PHONE NO : 719 9303217
20 Belle Air Rd SE DECISION MADE: 19-APR-23
Colorado Springs CO 80906 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Neuspera Nuity System
Neuspera Medical Inc. 510(k) NO: K221303(Traditional)
ATTN: Alexander Yeh PHONE NO : 888 8468332 703
51 Daggett Dr. SE DECISION MADE: 11-APR-23
San Jose CA 95134 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BNLE Access Guidewire
Biomerics NLE 510(k) NO: K221390(Traditional)
ATTN: Jason Albers PHONE NO : 763 4067137
10351 Xylon Ave N., Suite 100 SE DECISION MADE: 28-APR-23
Brooklyn Park MN 55445 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MicroScan Prompt Inoculation System-D
Beckman Coulter, Inc. 510(k) NO: K221493(Traditional)
ATTN: Sharon Cullen PHONE NO : 916 8442953
1584 Enterprise Blvd. SE DECISION MADE: 05-APR-23
West Sacramento CA 95691 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nightwear Aligners
Smylio Inc. 510(k) NO: K221537(Traditional)
ATTN: Ren Menon PHONE NO : 510 8682184
48890 Milmont Dr. Ste 101D SE DECISION MADE: 05-APR-23
Fremont CA 94538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Maxtec MaxO2 ME+p
Maxtec, LLC 510(k) NO: K221734(Traditional)
ATTN: Sidra Hankins PHONE NO : 1 732 2440010 1151
2305 South 1070 West SE DECISION MADE: 01-APR-23
Salt Lake City UT 84119 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CONNEQT PULSE
Atcor Medical 510(k) NO: K221742(Traditional)
ATTN: Toni Hofhine PHONE NO : 1 608 3546712
No. 3 Jin Ping Street,Ya An Road, SE DECISION MADE: 21-APR-23
Sydney AU 2000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: iSWAB-Respiratory Tract Sample Collection Media-Extraction Less (iSWAB-RC-EL)
Mawi DNA Technologies 510(k) NO: K221802(Traditional)
ATTN: Bassam EL-Fahmawi PHONE NO : 1 510 2565186
26203 Production Avenue, Suite 3 SE DECISION MADE: 03-APR-23
Hayward CA 94545 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BTL-094
BTL Industries Inc. 510(k) NO: K221865(Traditional)
ATTN: David Chmel PHONE NO : 1 866 2851656
362 Elm Street SE DECISION MADE: 14-APR-23
Marlborough MA 01752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Terumo Advanced Perfusion System 1
Terumo Cardiovascular Systems Corp510(k) NO: K221895(Traditional)
ATTN: Eileen Dorsey PHONE NO : 734 7416074
6200 Jackson Road SE DECISION MADE: 18-APR-23
Ann Arbor MI 48103 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cumulus Functional Neurophysiology Platform
Cumulus Neuroscience Limited 510(k) NO: K221963(Traditional)
ATTN: Caroline Kirwan PHONE NO : 44 028 92646600
The Innovation Center, Unit 4, QueSE DECISION MADE: 27-APR-23
Belfast IE BT3 9DT 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EpiFinder
Omeq Medical Ltd. 510(k) NO: K221974(Traditional)
ATTN: Lior Margalit PHONE NO : 972 722 607000
17 Tchelet St. Misgav Business ParSE DECISION MADE: 16-APR-23
M.P. Misgav IL 2017400 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Biodegradable Powder Free Nitrile Examination Glove, Blue Color, Biodegradable Powder Free Nitrile Examination Glove, Blue Violet Color, Biodegradable Powder Free Nitrile Examination Glove, Green Color
Guangdong Kingfa Sci. & Tech. Co.,510(k) NO: K221983(Traditional)
ATTN: Xiaoge Yu PHONE NO : 86 135 70952157
No.28, Delong Ave., Shijiao Town, SE DECISION MADE: 27-APR-23
Qingyuan CN 511545 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTEGRATE -C Interbody Fusion System
HAPPE Spine 510(k) NO: K222004(Traditional)
ATTN: Jenna Hollern PHONE NO : 1 616 8133880
220 Lyon Street, NW, Suite 500 SE DECISION MADE: 28-APR-23
Grand Rapids MI 49503 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sclerotherapy & Endoscopic Needles
G-Flex Europe SPRL 510(k) NO: K222006(Traditional)
ATTN: Thierry Cremer PHONE NO : 32 67 883665
20, Rue de l’industrie SE DECISION MADE: 03-APR-23
Nivelles BE 1400 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FAQ 101
Foreo, Inc. 510(k) NO: K222012(Traditional)
ATTN: Laura Hoshue PHONE NO : 561 2674702
1525 E. Pama Lane SE DECISION MADE: 05-APR-23
Las Vegas NV 89119 510(k) STATEMENT
DEVICE: RayFlow
Hexacath 510(k) NO: K222023(Traditional)
ATTN: Anthony Molliex PHONE NO : 33 1 41390192
4 Passage Saint Antoine SE DECISION MADE: 06-APR-23
Rueil Malmaison FR 92500 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LINK MobileLink Acetabular Cup System
Waldemar Link GmbH & Co KG 510(k) NO: K222066(Traditional)
ATTN: Stefanie Fuchs PHONE NO : 49 40 53995530
Oststrasse 4-10 SE DECISION MADE: 14-APR-23
Norderstedt DE 22844 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BASHIR Endovascular Catheter Ref. No. 7201, BASHIR S-B Endovascular Catheter, Ref. No. 7101
Thrombolex, Inc. 510(k) NO: K222095(Traditional)
ATTN: Amy Katsikas PHONE NO : 267 8983986
75 New Britain Dr. SE DECISION MADE: 20-APR-23
New Britain PA 18901 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Stratus Infusion Catheter
InterVene, Inc. 510(k) NO: K222185(Traditional)
ATTN: Jeff Elkins PHONE NO : 408 4642789
415 Grand Avenue, Suite 302 SE DECISION MADE: 13-APR-23
South San Francisco CA 94080 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: F&P Optiflow Junior 2/2+ Nasal Cannula Interface Range
Fisher & Paykel Healthcare Ltd 510(k) NO: K222197(Traditional)
ATTN: Reena Daken PHONE NO : 64 574 0100
15 Maurice Paykel Place, East TamaSE DECISION MADE: 06-APR-23
Auckland NZ 2013 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CIRRUS HD-OCT
Carl Zeiss Meditec Inc 510(k) NO: K222200(Traditional)
ATTN: Vidita Desai PHONE NO :
5300 Central Parkway SE DECISION MADE: 13-APR-23
Dublin CA 94568 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AEON Endoscopic Stapler
Lexington Medical Inc. 510(k) NO: K222210(Traditional)
ATTN: Rainer Maas PHONE NO : 978 2731946
23 Crosby Drive SE DECISION MADE: 21-APR-23
Bedford MA 01730 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Flexible Video-Choledochoscope System
Shanghai SeeGen Photoelectric Tech510(k) NO: K222261(Traditional)
ATTN: Yihua Ma PHONE NO : 21 542 95355
3 Floor, Building No.1, 4299 JinDuSE DECISION MADE: 20-APR-23
Shanghai CN 201108 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Paradigm System
Proprio, Inc. 510(k) NO: K222291(Traditional)
ATTN: Niyi Asimolowo PHONE NO : 206 8486301
111 W John Street Suite 308 SE DECISION MADE: 21-APR-23
Seattle WA 98119 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: The Heart Seat
Casana Care, Inc. 510(k) NO: K222330(Traditional)
ATTN: Kara Johnson PHONE NO : 603 4989607
150 Metro Park, Suite A SE DECISION MADE: 24-APR-23
Rochester NY 14623 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sterile Nitrile Surgical Gloves Powder Free
JR Engineering & Medical Technolog510(k) NO: K222350(Abbreviated)
ATTN: Ganesan Subramaniam PHONE NO : 603 60 572081____
Lot 8 &10, Jalan Zurah 3 & Lot 1&3SE DECISION MADE: 13-APR-23
Hulu Selangor MY 44200 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Epildream HP 4000 MED
D.E.A Project S.r.1. 510(k) NO: K222352(Traditional)
ATTN: Nico Guerini PHONE NO : 0039 035 771519
Via Italia, 16/interno A1 SE DECISION MADE: 27-APR-23
Mapello IT 24030 510(k) STATEMENT
DEVICE: AI-Rad Companion (Cardiovascular)
Siemens Medical Solutions U.S.A. 510(k) NO: K222360(Traditional)
ATTN: Alexandra Fink PHONE NO : 1610 2416736___
40 Liberty Blvd. SE DECISION MADE: 06-APR-23
Malvern PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SpO2 Extension Cable
Beijing Rongrui-Century Science & 510(k) NO: K222370(Traditional)
ATTN: Calen Chen PHONE NO : 86 769 22243880
3rd Floor, West zone, No.1 BuildinSE DECISION MADE: 02-APR-23
Beijing CN 100094 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating System
Stryker GmbH 510(k) NO: K222381(Traditional)
ATTN: Danielle Jannuzzi Madureira PHONE NO : 0041 798 900289
325 Corporate Drive SE DECISION MADE: 27-APR-23
Mahwah NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TIB Abutments
Southern Implants (Pty) Ltd 510(k) NO: K222469(Traditional)
ATTN: Leith C. Cumming PHONE NO : 27 12 6671046
1 Albert Road SE DECISION MADE: 17-APR-23
Irene ZA 0062 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Endo Motor
Shenzhen Perfect Medical Instrumen510(k) NO: K222548(Traditional)
ATTN: Kristy Mo PHONE NO : 86____ 139 29326975
Room 102, Building A, Ruiji FactorSE DECISION MADE: 26-APR-23
Shenzhen CN 518100 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EVIS X1 VIDEO SYSTEM CENTER OLYMPUS CV-1500, COLONOVIDEOSCOPE OLYMPUS CF-HQ1100DL/I, GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-1100
Olympus Medical Systems Corporatio510(k) NO: K222584(Traditional)
ATTN: Shinichiro Kawachi PHONE NO : 81 42 6422694
2951 Ishikawa-cho Hachioji-shi SE DECISION MADE: 26-APR-23
Tokyo JP 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: dentona flexisplint, optimill memosplint, dentona vivatemp, optimill memosplint version S
dentona AG 510(k) NO: K222604(Traditional)
ATTN: Andreas Foerster PHONE NO : 49____ 171 4424878
Otto-Hahn-Strasse 27 SE DECISION MADE: 21-APR-23
Dortmund DE 44227 510(k) STATEMENT
DEVICE: ET Abutment System
Hiossen Inc. 510(k) NO: K222636(Traditional)
ATTN: Peter Lee PHONE NO : 267 7597031
85 Ben Fairless Drive SE DECISION MADE: 28-APR-23
Fairless Hills PA 19030 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ceevra Reveal 3
Ceevra, Inc. 510(k) NO: K222676(Traditional)
ATTN: Ken Koster PHONE NO : 415 3254830
149 New Montgomery St, 4th Fl. SE DECISION MADE: 25-APR-23
San Francisco CA 94105 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Intermittent nelaton catheter for single use
Hangzhou Jimushi Meditech Co., Ltd510(k) NO: K222677(Traditional)
ATTN: Fenlong Wu PHONE NO : 86 571 85857559
Bldg. 1, No. 12 Longtan Road, CangSE DECISION MADE: 05-APR-23
Hangzhou CN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SmartGUIDE deflectable hydrophilic guidewire
Artiria Medical SA 510(k) NO: K222690(Traditional)
ATTN: Guillaume Petit-Pierre PHONE NO : 41 78 6490401
Campus Biotech B3 N06 Chemin des MSE DECISION MADE: 24-APR-23
Geneva CH CH-1202 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EmPro EPS (EP4514C-190, EP6514C-190);Nanoparasol EPS (PNP4514C-190,PNP6514C-190)
MicroVention, Inc. 510(k) NO: K222694(Traditional)
ATTN: Ganesh Balachandar PHONE NO : 213 6046748
35 Enterprise SE DECISION MADE: 27-APR-23
Aliso Viejo CA 92656 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Point implant system
PointNix Co., Ltd 510(k) NO: K222738(Traditional)
ATTN: Chang Nam Lee PHONE NO : 82 51 3633201
B1 and 3F, 7, Hyoyeol-ro SE DECISION MADE: 13-APR-23
Buk-gu KR 46509 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Insulin Pen Needle
Hantech Medical Device Co., Ltd. 510(k) NO: K222739(Traditional)
ATTN: Rachel Jin PHONE NO : 86 1805 8297039
No 288, Sanheng Road Changhe IndusSE DECISION MADE: 06-APR-23
Ningbo CN 315326 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Augmento
Deeptek Medical Imaging Private Li510(k) NO: K222781(Traditional)
ATTN: Kallol Sen PHONE NO : 91____ 980 4019133
3rd floor, Ideas to impact, PallodSE DECISION MADE: 11-APR-23
Pune IN 411045 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Curian® Shiga Toxin
Meridian Bioscience Inc. 510(k) NO: K222829(Traditional)
ATTN: Heather Planck PHONE NO : 513 9915946
3471 River Hills Drive SE DECISION MADE: 17-APR-23
Cincinnati OH 45244 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: M Biopsy /SureCore Automatic Disposable Biopsy Needle, M Biopsy /SureCore Semi-Automatic Disposable Biopsy Needle, M Biopsy /SureAim Coaxial Biopsy Needle
Canyon Medical Inc. 510(k) NO: K222865(Traditional)
ATTN: Huiqi Jiang PHONE NO : 86 1324 1196637
Building 3, Phase 2 Accelerator, NSE DECISION MADE: 03-APR-23
Nanjing CN 210032 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Arm Blood Pressure Monitor/Automatic Wireless Smart Blood Pressure Monitor
Famidoc Technology Company Limited510(k) NO: K222887(Traditional)
ATTN: Amos Zou PHONE NO : 86 769 89272488
No. 212 Yilong Road, Hexi IndustriSE DECISION MADE: 10-APR-23
Dongguan CN 523853 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Axiostat Gauze
Advamedica Inc. 510(k) NO: K222909(Traditional)
ATTN: Leo Mavely PHONE NO : 973 7187575
Harvard Square 1, Mifflin Place, SSE DECISION MADE: 07-APR-23
Cambridge MA 02138 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Bronchoscope System
Shenzhen HugeMed Medical Technical510(k) NO: K222910(Traditional)
ATTN: Cathy S PHONE NO : 86 755 22275833
416-1, 516-1, Building 2, No. 1, MSE DECISION MADE: 11-APR-23
Shenzhen CN 518100 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nanox.ARC
Nano-X Imaging Ltd. 510(k) NO: K222934(Traditional)
ATTN: Erez Meltzer PHONE NO : 972 524 444044
Communications Center, Bldg. C, EnSE DECISION MADE: 28-APR-23
Neve Ilan IL 9085000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Access PCT
Beckman Coulter, Inc 510(k) NO: K222996(Traditional)
ATTN: Neha Desai PHONE NO : 612 2449788
1000 Lake Hazeltine Drive SE DECISION MADE: 26-APR-23
Chaska MN 55318 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OSPREY PERIPHERAL IV Catheter System
SkyDance Vascular, Inc. 510(k) NO: K223018(Traditional)
ATTN: Scott Pease PHONE NO : 678 6898010
3058 Millcreek Road SE DECISION MADE: 14-APR-23
Pleasant Grove UT 84062 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Peri-Guard and Supple Peri-Guard
Synovis Life Technologies, Inc. 510(k) NO: K223052(Traditional)
ATTN: Megan Sajjad PHONE NO : 414 2181464
A Subsidiary of Baxter InternationSE DECISION MADE: 07-APR-23
St. Paul MN 55114 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Modular Rotating Hinge Knee Systems and Compatible Components
Howmedica Osteonics Corp. dba Stry510(k) NO: K223069(Traditional)
ATTN: Margaret Klippel PHONE NO : 201 8315559
325 Corporate Drive SE DECISION MADE: 21-APR-23
Mahwah NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD SmartSite™ Needle-Free Connector
CareFusion 510(k) NO: K223088(Traditional)
ATTN: Jacob Lee PHONE NO : 385 2550184
10020 Pacific Mesa Blvd SE DECISION MADE: 07-APR-23
San Diego CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Wallaby 017 Micro Catheter
Wallaby Medical 510(k) NO: K223139(Traditional)
ATTN: Joseph Tang PHONE NO : 714 9046097
22901 Mill Creek Drive SE DECISION MADE: 25-APR-23
Laguna Hills CA 92653 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STR8 Clear Aligner
STR8 Oral Care 510(k) NO: K223141(Traditional)
ATTN: Misee Harris PHONE NO : 931 7971821
217 E Cherry Ave SE DECISION MADE: 24-APR-23
Jonesboro AR 72401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Tubing and Accessories Sets for Extracorporeal Membrane Oxygenation (ECMO) with Balance™ Biosurface
Medtronic Inc. 510(k) NO: K223168(Traditional)
ATTN: Anna Wetherille PHONE NO : 763 5059456
8200 Coral Sea St. NE SE DECISION MADE: 19-APR-23
Mounds View MN 55112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cleaner Plus™ Thrombectomy System, Cleaner Plus™ Aspiration Catheter, Cleaner Plus™ Handpiece with 65cm Maceration Wire, Cleaner Plus™ Handpiece with 135cm Maceration Wire, Cleaner Plus™ Aspiration Canister
Argon Medical Devices, Inc. 510(k) NO: K223176(Special)
ATTN: Ana Jimenez-Hughes PHONE NO : 903 6764276
1445 Flat Creek Road SE DECISION MADE: 10-APR-23
Athens TX 75751 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TAP Lancet
YourBio Health, Inc. 510(k) NO: K223201(Traditional)
ATTN: Sean McCarthy PHONE NO : 617 4356023
200 Boston Avenue Suite 3700 SE DECISION MADE: 19-APR-23
Medford MA 02155 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ClotTriever XL Catheter
Inari Medical, Inc. 510(k) NO: K223210(Traditional)
ATTN: Kaitlyn Weinkauf PHONE NO : 949 4184116
6001 Oak Canyon, Suite 100 SE DECISION MADE: 27-APR-23
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Precision DL
GE Healthcare 510(k) NO: K223212(Traditional)
ATTN: George Mashour PHONE NO : 972 54 7464808
4 Hayozma Street SE DECISION MADE: 27-APR-23
Tirat Hacarmel IL 30200 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STARband 3D
Orthomerica Products Inc. 510(k) NO: K223238(Traditional)
ATTN: David C Kerr PHONE NO : 407 2906592
6333 North Orange Blossom Trail SE DECISION MADE: 20-APR-23
Orlando FL 32810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Annalise Enterprise CTB Triage Trauma
Annalise-AI Pty Ltd 510(k) NO: K223240(Traditional)
ATTN: Haylee Bosshard PHONE NO : 61 493 266602
Level 21, 60 Margaret St. SE DECISION MADE: 03-APR-23
Sydney AU 2000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Optimos™ Cystotome
Taewoong Medical Co., Ltd. 510(k) NO: K223256(Traditional)
ATTN: Yongjin Jeff Kim PHONE NO : 82 31 99606414 222
14 Gojeong-Ro, Wolgot-Myeon SE DECISION MADE: 05-APR-23
Gimpo-Si KR 10022 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Velacur
Sonic Incytes 510(k) NO: K223287(Traditional)
ATTN: Barry Allen PHONE NO :
#309-1788 West 5th Ave SE DECISION MADE: 20-APR-23
Vancouver CA V6J 1P2 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Estacore-Pro Automatic Biopsy Needle, Geotek Semiautomatic Biopsy Needle, Maxicore-M Automatic Biopsy Gun Needle, Maxicore-M Automatic Biopsy Needle and Instrument
GEOTEK Medikal Ltd sti 510(k) NO: K223300(Traditional)
ATTN: Latif Iba PHONE NO : 90 312 3959852
Ivedik OSB, Agac Metal Sitesi 1436SE DECISION MADE: 21-APR-23
Ankara TR 06378 510(k) STATEMENT
DEVICE: Antimicrobial Silicone PHMB Foam Wound Dressing
Advanced Medical Solutions Limited510(k) NO: K223310(Special)
ATTN: Kay Mcgrath PHONE NO : 44 1606 863500
Premier Park, 33 Road One WinsfordSE DECISION MADE: 05-APR-23
Winsford GB CW7 3RT 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Task Force CORE
CNSystems Medizintechnik GmbH 510(k) NO: K223332(Traditional)
ATTN: Raphael Gunacker PHONE NO : 0043 316 7234560
Reininghausstrasse 13 SE DECISION MADE: 12-APR-23
Graz AT 8020 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Omnipod GO Insulin Delivery Device
Insulet Corporation 510(k) NO: K223372(Traditional)
ATTN: Lauren Davis PHONE NO : 978 6007000
100 Nagog Park SE DECISION MADE: 24-APR-23
Acton MA 01720 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Enivo™
Aroa Biosurgery Ltd. 510(k) NO: K223373(Traditional)
ATTN: Tina O'Brien PHONE NO : 64____ 0986 93035_____
2 Kingsford Smith Place SE DECISION MADE: 07-APR-23
Airport Oaks NZ 2022 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Gastric Alimetry System
Alimetry Ltd. 510(k) NO: K223398(Traditional)
ATTN: Yaara Yarmut PHONE NO : 64 276 091886
70 Symonds Street SE DECISION MADE: 27-APR-23
Grafton NZ 1010 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose Monitoring System
Abbott Diabetes Care Inc. 510(k) NO: K223435(Traditional)
ATTN: Katherine L. Doll Kanne PHONE NO : 612 3949209
1360 South Loop Road SE DECISION MADE: 13-APR-23
Alameda CA 94502 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Custom-made Invisible Aligners
Zhejiang Yinchili Medical Technolo510(k) NO: K223454(Traditional)
ATTN: Xinyan Zhang PHONE NO : 86 158 00780940
North 4F, No.239 Yatai Road Nanhu SE DECISION MADE: 17-APR-23
Jiaxing CN 314000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, MR 5300 and MR 7700 MR Systems
Philips Medical Systems Nederland 510(k) NO: K223458(Abbreviated)
ATTN: Ioana Ulea PHONE NO : 31 618 345875
Veenpluis 6, SE DECISION MADE: 06-APR-23
Best NL 5684PC 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ViewFinder Software Version 1.1
Elaitra Ltd 510(k) NO: K223501(Traditional)
ATTN: Stephen Morrell PHONE NO : 44 7771 806100
8B Buckland Crescent, Belsize ParkSE DECISION MADE: 21-APR-23
London GB NW3 5DX 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Compremium Compartment Compressibility Monitoring System (CPM#1)
Compremium AG 510(k) NO: K223509(Traditional)
ATTN: Vincent Baumann PHONE NO : 41 79 9339648
Worbstrasse 46 SE DECISION MADE: 14-APR-23
Muri b. Bern CH 3074 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UniVy™ OsteoVy™-Ti Cervical IBF System
Vy Spine, LLC 510(k) NO: K223513(Special)
ATTN: Jordan Hendrickson PHONE NO : 866 4897746
2236 Capital Circle NE, Suite 103-SE DECISION MADE: 18-APR-23
Tallahassee FL 32308 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UNIDRIVE SIII System
Karl Storz-Endoscopy-America, Inc.510(k) NO: K223520(Traditional)
ATTN: Alita McElroy PHONE NO : 424 2188376
2151 E. Grand Avenue SE DECISION MADE: 27-APR-23
El Segundo CA 90245 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Route 92 Medical Full Length 070 Reperfusion System and Aspiration Tubing Set
Route 92 Medical, Inc. 510(k) NO: K223530(Traditional)
ATTN: Kirsten Valley PHONE NO : 650 2798427
155 Bovet Road, Suite 100 SE DECISION MADE: 11-APR-23
San Mateo CA 94402 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, CARESCAPE Canvas D19, F2 Frame (F2-01)
GE Healthcare Finland Oy 510(k) NO: K223531(Traditional)
ATTN: Joel Kent PHONE NO : 617 8510943
Kuortaneenkatu 2 SE DECISION MADE: 06-APR-23
Helsinki FI FI-00510 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DMX
Del Medical, Inc. 510(k) NO: K223550(Abbreviated)
ATTN: Greg Geary PHONE NO : 847 2887000
241 Covington Drive SE DECISION MADE: 10-APR-23
Bloomingdale IL 60108 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Brainlab Elements – Trajectory Planning (2.6), Elements Stereotaxy, Elements Lead Localization, Elements Trajectory Planning Cranial
Brainlab AG 510(k) NO: K223552(Traditional)
ATTN: Sadwini Suresh PHONE NO : 49 8999 15680
Olof-Palme-Str.9 SE DECISION MADE: 19-APR-23
Munich DE 81829 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: X-CUBE 50, X-CUBE 60
Alpinion Medical Systems Co., Ltd.510(k) NO: K223564(Traditional)
ATTN: Boyeon CHO PHONE NO : 82 2 37778600
4F, 15, Magokjunang 14-ro, GangseoSE DECISION MADE: 17-APR-23
Seoul KR 07789 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELITA™ Femtosecond Laser System, ELITA™ Patient Interface
Johnson & Johnson Surgical Vision,510(k) NO: K223566(Traditional)
ATTN: Amanda Houston PHONE NO : 562 7748122
31 Technology Drive SE DECISION MADE: 14-APR-23
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Localite TMS Navigator TS
Localite GmbH 510(k) NO: K223577(Traditional)
ATTN: Arno Schmitgen PHONE NO : 0049 2284 1012220
Auguststr. 1 SE DECISION MADE: 17-APR-23
Bonn DE 53229 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Reveal LINQ Insertable Cardiac Monitor, LINQ II Insertable Cardiac Monitor, AccuRhythm AI ECG Classification System
Medtronic, Inc. 510(k) NO: K223630(Traditional)
ATTN: Kerry Luyster PHONE NO : 763 5052128
8200 Coral Sea Street NE SE DECISION MADE: 05-APR-23
Mounds View MN 55112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Customized Abutment
Arum Dentistry Co., Ltd. 510(k) NO: K223634(Traditional)
ATTN: Boyeon Lim PHONE NO : 82 42 9353644
23, Gukjegwahak 11-ro, Yuseong-gu SE DECISION MADE: 28-APR-23
Daejeon KR 34002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Axoguard HA+ Nerve Protector (AGHA12); Axoguard HA+ Nerve Protector (AGHA22); Axoguard HA+ Nerve Protector (AGHA24); Axoguard HA+ Nerve Protector (AGHA36); Axoguard HA+ Nerve Protector (AGHA48)
AxoGen Corporation 510(k) NO: K223640(Traditional)
ATTN: Jonathan White PHONE NO : 386 4626800
13631 Progress Blvd, Ste 400 SE DECISION MADE: 07-APR-23
Alachua FL 32615-9409 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Neodent Implant System - Helix Short Surgical Kit Cases
JJGC Industria e Comercio de Mater510(k) NO: K223662(Traditional)
ATTN: Barbara Uzae PHONE NO : 55 41 21694058
Av. Juscelino Kubitschek de OliveiSE DECISION MADE: 20-APR-23
Curitiba BR 81270-200 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Titanium Abutment Blank Nobel Biocare N1 TCC
Nobel Biocare AB 510(k) NO: K223677(Traditional)
ATTN: Bernice Jim PHONE NO : 41 79 8550073
Vastra Hamngatan 1 SE DECISION MADE: 28-APR-23
Goteborg SE SE 411 17 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EndoflipTM 300
Covidien LLC 510(k) NO: K223705(Traditional)
ATTN: Liron Bar Yaakov PHONE NO : 720 4229135
3062 Bunker Hill Lane SE DECISION MADE: 14-APR-23
Santa Clara CA 95054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENT EM
Brainlab AG 510(k) NO: K223734(Traditional)
ATTN: Esther Moreno Garcia PHONE NO : 49 8999 15680
Olof-Palme-Str. 9 SE DECISION MADE: 27-APR-23
Munich DE 81829 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZeptoLink IOL Positioning System
Centricity Vision, Inc. 510(k) NO: K223763(Traditional)
ATTN: Neal Hartman PHONE NO : 858 3826550
1939 Palomar Oaks Way, Suite A SE DECISION MADE: 11-APR-23
Carlsbad CA 92011 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RadiForce RX270
EIZO Corporation 510(k) NO: K223768(Abbreviated)
ATTN: Hiroaki Hashimoto PHONE NO : 81 76 2742468
153 Shimokashiwano SE DECISION MADE: 20-APR-23
Hakusan JP 924-8566 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRO Plating System, Stryker Trauma Pelvic Set (Matta)
Stryker GMbH 510(k) NO: K223772(Traditional)
ATTN: Danielle Jannuzzi Madureira PHONE NO : 0041 798 900289
325 Corporate Drive SE DECISION MADE: 07-APR-23
Mahwah NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Contour ProtégéAI
MIM Software Inc. 510(k) NO: K223774(Traditional)
ATTN: Lynn Hanigan PHONE NO : 216 4550600
25800 Science Park Drive Suite 180SE DECISION MADE: 06-APR-23
Cleveland OH 44122 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Precision TC2, Precision TC3, Precision TC4, SEG 100, SEG 100+, SEG 150+, SEG200, SEG200+
Deltronix Equipamentos Ltda 510(k) NO: K223784(Traditional)
ATTN: Carlos Paulim PHONE NO : 55 16 40095454
Rua Barao de Cotegipe, 776 SE DECISION MADE: 18-APR-23
Ribeirao Preto BR 14050-420 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: N9+
Nonagon Ltd. 510(k) NO: K223785(Traditional)
ATTN: Orly Maor PHONE NO : 972 54 7276691
1 HaEshel St. SE DECISION MADE: 14-APR-23
Caesarea IL 3079830 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Dental CT Scanner AXR
Alliage S/A Industrias Medico Odon510(k) NO: K223816(Abbreviated)
ATTN: Daniel Camargo PHONE NO : 55 16 35121212
Rod. Abrão Assed, Km 53+450m SE DECISION MADE: 07-APR-23
Recreio Anhanguera BR 14097-500 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ultrasound System 2300
BK Medical Aps 510(k) NO: K223830(Traditional)
ATTN: Inesa Cernajute PHONE NO : 45 422 77733
Mileparken 34 SE DECISION MADE: 11-APR-23
Herlev DK 2730 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Catalys™ Precision Laser System
AMO Manufacturing USA, LLC 510(k) NO: K223838(Traditional)
ATTN: Laarni Ricafort PHONE NO : 408 2734016
510 Cottonwood Drive SE DECISION MADE: 12-APR-23
Milpitas CA 95035 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Hair Boom 69, Hair BoomAir, Hair Boom, Ulike Hair UpUp
Won Tech Co., Ltd. 510(k) NO: K223862(Special)
ATTN: Hyun Sik Yoon PHONE NO : 82 10 67505346
64 Techno 8-Ro, Yuseong-gu SE DECISION MADE: 28-APR-23
Daejeon KR 34028 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PYXIS 3D Titanium Cage System
GS Medical Co. Ltd. 510(k) NO: K223868(Traditional)
ATTN: Sam Camp PHONE NO : 352 3274641
90, Osongsaengmyeong 4-ro Osong-euSE DECISION MADE: 26-APR-23
Cheongui-si KR 28161 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Quantum PureFlow Standard Heat Exchangers (HX11W-S2, HX11W-S1M and HX11W-S2M)
Quara S.r.l. 510(k) NO: K223879(Special)
ATTN: Raffaella Tommasini PHONE NO : 39 0535 1803050
Via di Mezzo, 23 SE DECISION MADE: 13-APR-23
Mirandola IT 41037 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DentMix VPS Impression Material
Innovative Product Brands, Inc. 510(k) NO: K223892(Traditional)
ATTN: Shane Nielsen PHONE NO : 1_____ 801 5401136
7045 Palm Avenue SE DECISION MADE: 27-APR-23
Highland CA 92346 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SafeAir combi (SFR-combi-US)
LiNA Medical ApS 510(k) NO: K223932(Traditional)
ATTN: Jaroslaw Mrowczynski PHONE NO : 48 61 2222121___
Formervangen 5 SE DECISION MADE: 26-APR-23
Glostrup DK DK-2600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ADSEAL Plus
Meta Biomed Co., LTD. 510(k) NO: K230010(Traditional)
ATTN: Suk Song Oh PHONE NO : 82 43 2308841
270, Osong saengmyeong 1-ro, OsongSE DECISION MADE: 13-APR-23
Cheongju-si KR 28161 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ART-Plan
Therapanacea SAS 510(k) NO: K230023(Special)
ATTN: Catherine Martineau-Huynh PHONE NO : 33 9 62527819
7 bis boulevard Bourdon SE DECISION MADE: 19-APR-23
Paris FR 75004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Kendall SCD SmartFlow Controller, Cardinal Health Element Sleeves, Kendall SCD Express Sleeves, Kendall SCD Express Foot Cuff, Kendall SCD Sequential Compression Comfort Sleeves, Kendall SCD SmartFlow Controller Tubing Assembly
Cardinal Health200, LLC 510(k) NO: K230028(Traditional)
ATTN: Katy Piper PHONE NO : 1 847 8876085 ______
3651 Birchwood Drive SE DECISION MADE: 03-APR-23
Waukegan IL 60085 510(k) STATEMENT
DEVICE: NeuroStar Advanced Therapy System (Version 3.7)
Neuronetics 510(k) NO: K230029(Traditional)
ATTN: Amanda Pentecost PHONE NO : 610 6404202
3222 Phoenixville Pike SE DECISION MADE: 04-APR-23
Malvern PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Da Vinci SP Surgical System (SP1098)
Intuitive Surgical Inc. 510(k) NO: K230033(Traditional)
ATTN: Mike Yramategui PHONE NO : 408 5944207
1020 Kifer Rd. SE DECISION MADE: 05-APR-23
Sunnyvale CA 94086 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BioSci™ Disposable Virus Sampling Tubes
Shenzhen Dakewe Bio-engineering Co510(k) NO: K230035(Traditional)
ATTN: Jiang Wei PHONE NO : 86____ 1552 1377325
Room 702-703, Building No.1,ShenzhSE DECISION MADE: 05-APR-23
Shenzhen CN 518122 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Q-Rejuvalight Pro Facewear (Model: P19-0023)
Light Tree Ventures Europe B.V. 510(k) NO: K230042(Traditional)
ATTN: Alain Dijkstra PHONE NO : 86 135 10378748
Laan van Ypenburg 108, 2497 GC, ThSE DECISION MADE: 28-APR-23
Hague NL 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SimpliFix Hip System
Stabiliz Orthopaedics Inc. 510(k) NO: K230053(Traditional)
ATTN: Douglas Cerynik PHONE NO : 610 4588555
600 Eagleview Blvd Unit 300 SE DECISION MADE: 19-APR-23
Exton PA 19341 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MiVu™ Esophageal Endo Cap
Diversatek Healthcare 510(k) NO: K230056(Traditional)
ATTN: Jim Prinster PHONE NO : 303 8658028
9150 Commerce Center Circle, SuiteSE DECISION MADE: 25-APR-23
Highlands Ranch CO 80129 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Bladeless Trocar – Artemis Lap Cannula
T.A.G. Medical Products Corporatio510(k) NO: K230058(Traditional)
ATTN: Shlomi Dines PHONE NO : 972 4 9858400
T.A.G. Medical Products CorporatioSE DECISION MADE: 28-APR-23
Gaaton IL 2513000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Mazor X System (Mazor X Stealth Edition)
Mazor Robotics Ltd. 510(k) NO: K230064(Traditional)
ATTN: Rishi Sinha PHONE NO : 720 8902485
1 HaEshel Street (Building C) SE DECISION MADE: 07-APR-23
Caesarea Business Park IL 3079830510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: S.I.N. Dental Implant System
S.I.N. – Sistema de Implante Nacio510(k) NO: K230069(Traditional)
ATTN: Denise Domiciano PHONE NO : 55 11 21693000 3236
Avenida Vereador Abel Ferreira, 11SE DECISION MADE: 06-APR-23
São Paulo BR 03340-000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound System
Samsung Medison CO., LTD. 510(k) NO: K230084(Traditional)
ATTN: So-yeon Jang PHONE NO : 82 221 940875
3366, Hanseo-ro, Nam-myeon SE DECISION MADE: 21-APR-23
Hongcheon-gun KR 25108 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Diode Laser Hair Removal
Wuhan Lotuxs Technology Co., Ltd. 510(k) NO: K230090(Traditional)
ATTN: Na Wu PHONE NO : 86 138 71252776
501/E2, Future City, No.999 high-tSE DECISION MADE: 19-APR-23
Wuhan CN 430075 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IPL Hair Removal Device, Model(s): BSXT101, BSXT102, BSXT103, BSXT105, BSXT106, BSXT108
Shenzhen BSX Technology Electronic510(k) NO: K230097(Traditional)
ATTN: Hong Li PHONE NO : 86 18133 439986
Rm101&2/F~4/F, Building No.13, AilSE DECISION MADE: 06-APR-23
Shenzhen CN 518116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Trusana™
Myerson, LLC 510(k) NO: K230098(Traditional)
ATTN: James H Swartout PHONE NO : 312 4328200
5106 North Ravenswood Avenue SE DECISION MADE: 13-APR-23
Chicago IL 60640-2713 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Klockner Abutments
Soadco, S.L. 510(k) NO: K230103(Traditional)
ATTN: Mercedes Roldan PHONE NO : 37 6 800590
Av. del Pessebre, 76-82, Baixos SE DECISION MADE: 24-APR-23
Escaldes - Engordany AD AD-700 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Aimanfun Lumea Comfort, Model: A-2788, A-2789 and A-3588
Kam Yuen Plastic Products Ltd. 510(k) NO: K230107(Traditional)
ATTN: Anna Dan PHONE NO : 86 400 9621668
No. 2, Heng Feng Two Road, Pu Jin SE DECISION MADE: 05-APR-23
ZhongShan CN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IPL Hair Removal Device, Model(s): UI04 SD, UI04 DG
Shenzhen Ulike Smart Electronics C510(k) NO: K230122(Traditional)
ATTN: Shane Xie PHONE NO : 86 18600 825411
No.8, Keyuan Road, Yuehai Sub-distSE DECISION MADE: 10-APR-23
Shenzhen CN 518000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TrueView 200 Pro-US Specimen Radiography System (TrueView 200 Pro-US)
CompAI Healthcare (Suzhou) Co.,ltd510(k) NO: K230136(Traditional)
ATTN: Xueqiao Wang PHONE NO : 86 189 14039759
Room 3A05, Building 2, No.8 ChangtSE DECISION MADE: 24-APR-23
Suzhou CN 215151 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TrueView Core 100Pro-US Core Specimen Radiography System (TrueView Core 100Pro-US)
CompAI Healthcare (Suzhou) Co.,ltd510(k) NO: K230140(Traditional)
ATTN: Xueqiao Wang PHONE NO : 86 189 14039759
Room 3A05, Building 2, No.8 ChangtSE DECISION MADE: 24-APR-23
Suzhou CN 215151 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DESS Dental Smart Solutions
Terrats Medical SL 510(k) NO: K230143(Traditional)
ATTN: Roger Terrats PHONE NO : 34 935 646006
Carrer Mogoda 75-99 SE DECISION MADE: 13-APR-23
Barbera del Valles ES 08210 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TENS and EMS Stimulation (OTC)
Changsha Yuwen Medical Equipment C510(k) NO: K230164(Traditional)
ATTN: Chen Dahui PHONE NO : 86 199 73129555
Room 2404, Kairui Building, No. 24SE DECISION MADE: 10-APR-23
Changsha CN 430103 510(k) STATEMENT
DEVICE: EMPOWR Revision VVC+ (Varus / Valgus Constrained), e+ Tibial Insert
Encore Medical, L.P. dba Enovis 510(k) NO: K230169(Traditional)
ATTN: Trey Thorsen PHONE NO : 850 4503932
9800 Metric Boulevard SE DECISION MADE: 06-APR-23
Austin TX 78758 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TMINI™ Miniature Robotic System
THINK Surgical, Inc. 510(k) NO: K230202(Traditional)
ATTN: Meliha Mulalic PHONE NO : 510 2492337
47201 Lakeview Blvd SE DECISION MADE: 25-APR-23
Fremont CA 94538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALPHALOK Plating System
Vilex LLC 510(k) NO: K230204(Traditional)
ATTN: Brock Johnson PHONE NO : 801 9164157
111 Moffitt Street SE DECISION MADE: 25-APR-23
McMinnville TN 37110 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series)
Dental Direkt GmbH 510(k) NO: K230218(Traditional)
ATTN: Patrick Berz PHONE NO : 49 5225 863190____
Industriezentrum 106-108 SE DECISION MADE: 25-APR-23
Spenge DE 32139 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: iCAC Device
Bunkerhill, Inc 510(k) NO: K230223(Traditional)
ATTN: Nishith Khandwala PHONE NO : 650 8420198
428 El Verano Ave SE DECISION MADE: 25-APR-23
Palo Alto CA 94306 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ezra Flash
Ezra AI, Inc. 510(k) NO: K230264(Traditional)
ATTN: David Girard PHONE NO : 646 4025751
419 Park Ave S, Suite 600 SE DECISION MADE: 13-APR-23
New York NY 10016 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Renuvion® APR Handpiece
Apyx Medical Corporation 510(k) NO: K230272(Traditional)
ATTN: Angela Huber PHONE NO : 218 3434881
5115 Ulmerton Road SE DECISION MADE: 27-APR-23
Clearwater FL 33760-4004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QUANTUM Patient Specific Instrumentation (PSI) System
In2Bones SAS 510(k) NO: K230313(Traditional)
ATTN: Sabina Ahaddad PHONE NO : 33 472 292626
26 Chemin du Petit Bois SE DECISION MADE: 06-APR-23
Ecully FR 69130 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Memo 3D Semirigid Annuloplasty Ring; Memo 3D ReChord Semirigid Annuloplasty Ring; Memo 4D Semirigid Annuloplasty Ring
Corcym S.r.l. 510(k) NO: K230318(Traditional)
ATTN: Silvia Contadini PHONE NO : 39 349 9345991
Via Crescentino Sn SE DECISION MADE: 07-APR-23
Saluggia IT 13040 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CurrentBody Skin™ Led Hair Regrowth(Model: MZ-07)
Light Tree Ventures Europe B.V. 510(k) NO: K230336(Traditional)
ATTN: Alain Dijkstra PHONE NO : 86 135 10378748
Laan van Ypenburg 108, 2497 GC, ThSE DECISION MADE: 05-APR-23
Hague NL 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACRIFIX
DeltaMed GmbH 510(k) NO: K230341(Traditional)
ATTN: Michael Zimmermann PHONE NO : 0049 6031 728317
Raiffeisenstrasse 8a SE DECISION MADE: 06-APR-23
Friedberg DE 61169 510(k) STATEMENT
DEVICE: IPL Cooling Hair Removal Device, Model(s): NBB01, NBB02
Shenzhen Jizhimei Technology Co., 510(k) NO: K230360(Traditional)
ATTN: Guo Miaosi PHONE NO : 86 159 76876862
Building A203, Building A/B, Zone SE DECISION MADE: 10-APR-23
Shenzhen CN 518000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Arthrex Univers Revers Monoblock Stem Size 4/33
Arthrex Inc. 510(k) NO: K230366(Traditional)
ATTN: Tiffany Mentzel PHONE NO : 239 6435553 75833_
1370 Creekside Boulevard SE DECISION MADE: 10-APR-23
Naples FL 34108-1945 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ballancer Platinum (1222)
Mego Afek 510(k) NO: K230385(Traditional)
ATTN: Yunger Reuven PHONE NO : 972 77 9084276___
Kibbuts Afek SE DECISION MADE: 04-APR-23
Kibbuts Afek IL 3004200 510(k) STATEMENT
DEVICE: ENSEAL X1 Curved Tissue Sealers, 25 cm shaft length (NSLX125C); ENSEAL X1 Curved Tissue Sealers, 37 cm shaft length (NSLX137C); ENSEAL X1 Curved Tissue Sealers, 45 cm shaft ength (NSLX137C); ENSEAL X1 Straight Tissue Sealers, 25 cm shaft length (NSLX125S); ENSEAL X1 Straight Tissue Sealers, 37 cm shaft length (NSLX137S)
Ethicon Endo-Surgery, LLC 510(k) NO: K230387(Traditional)
ATTN: Ekta Patel PHONE NO : 513 3371124
475 Calle C SE DECISION MADE: 13-APR-23
Guaynabo PR 00969 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UniCam Evo Software
Inter Medical Medizintechnik GmbH 510(k) NO: K230393(Traditional)
ATTN: Hans-Guenter Osiek PHONE NO : 490 57 4123590
Daimlerstrasse 34-36 SE DECISION MADE: 13-APR-23
Luebbecke DE D-32312 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENROUTE® Transcarotid Neuroprotection System
Silk Road Medical 510(k) NO: K230402(Special)
ATTN: Denise Aycox PHONE NO : 619 7465700
1213 Innsbruck Drive SE DECISION MADE: 11-APR-23
Sunnyvale CA 94089 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Dragonfly OpStar™ Imaging Catheter
Abbott Medical 510(k) NO: K230411(Traditional)
ATTN: Derek Pike PHONE NO : 978 5773595
4 Robbins Road SE DECISION MADE: 14-APR-23
Westford MA 01886 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Symmed Elite Aesthetic
TermoSalud 510(k) NO: K230412(Traditional)
ATTN: Cristina Cifuentes Pantoja PHONE NO : 34 985 167547
Calle Ataulfo Friera Tarfe, 8-3321SE DECISION MADE: 13-APR-23
Gijon ES 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Omnia Medical Coupler-A™ Anterior Lumbar Plate System; Omnia Medical Coupler-L™ Lateral Lumbar Plate System
Omnia Medical, LLC 510(k) NO: K230424(Traditional)
ATTN: Troy Schifano PHONE NO : 304 4134851
6 Canyon Rd SE DECISION MADE: 12-APR-23
Morgantown WV 26508 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Tigertriever 21 Revascularization Device, Tigertriever 17 Revascularization Device, Tigertriever 13 Revascularization Device
Rapid Medical Ltd. 510(k) NO: K230429(Special)
ATTN: Orit Yaniv PHONE NO : 972 722 503331
Carmel Building, POB 337 SE DECISION MADE: 17-APR-23
Yokneam IL 2069205 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EzDent Web
Ewoosoft Co., Ltd 510(k) NO: K230468(Traditional)
ATTN: Young Seok Kim PHONE NO : 82 31 80156172
801-ho, Vatechnetworks Bldg., 13, SE DECISION MADE: 21-APR-23
Hwaseong-si KR 18449 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Weck Auto Endo5 5mm Automatic Endoscopic 35cm Applier (AE05ML)
Teleflex Medical 510(k) NO: K230480(Special)
ATTN: Hope West PHONE NO : 919 4334821
3015 Carrington Mill Blvd SE DECISION MADE: 28-APR-23
Morrisville NC 27560 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ClotTriever BOLD Catheter
Inari Medical, Inc. 510(k) NO: K230494(Traditional)
ATTN: Kaitlyn Weinkauf PHONE NO : 714 6152605
6001 Oak Canyon, Suite 100 SE DECISION MADE: 18-APR-23
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ArtiSential Laparoscopic Instruments-Electrodes
LivsMed Inc. 510(k) NO: K230499(Traditional)
ATTN: Dong Wook Lee PHONE NO : 82 707 7094993
#304, D-dong, 700, Pangyo-ro, BundSE DECISION MADE: 26-APR-23
Seongnam-si KR 13516 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Polaris X™ Catheter Cable, Blazer™ Dx-20 Catheter Cable
Boston Scientific 510(k) NO: K230503(Traditional)
ATTN: Stephanie Andre PHONE NO : 651 5825544
4100 Hamline Ave N SE DECISION MADE: 25-APR-23
St.Paul MN 55112-5798 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ArtiSential Laparoscopic Instruments-Electrodes
LivsMed Inc. 510(k) NO: K230539(Traditional)
ATTN: Dong Wook Lee PHONE NO : 82 707 7094993
#304, D-dong, 700, Pangyo-ro, BundSE DECISION MADE: 27-APR-23
Seongnam-si KR 13516 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SnugFit All-Suture Anchor extension
Medacta International S.A. 510(k) NO: K230544(Special)
ATTN: Stefano Baj PHONE NO : 41 91 6966060
Strada Regina SE DECISION MADE: 17-APR-23
Castel San Pietro CH 6874 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PlumePen Elite Surgical Smoke Evacuation Pencils, PlumePen Pro Surgical Smoke Evacuation Pencil, PlumePen Ultra Surgical Smoke Evacuation Pencils, PenAdapt Electrosurgical Pencil Adapter, SnapEvac Electrosurgical Pencil Adapter
ConMed Corporation 510(k) NO: K230547(Traditional)
ATTN: Ali AbuSaleh PHONE NO : 708 4074324
525 French Road SE DECISION MADE: 27-APR-23
Utica NY 13502 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IPL Hair Removal Device, Model(s): FY-B505AL, FY-B505AG, FY-B505BL, FY-B505BG, FY-B507AL, FY-B507AG, FY-B507BL, FY-B507BG, FY-B508AL, FY-B508AG, FY-B508BL, FY-B508BG, FY-B509AL, FY-B509AG, FY-B509BL, FY-B509BG
Shenzhen Xiazhifeng Electronic Co.510(k) NO: K230549(Traditional)
ATTN: James Li PHONE NO : 86 137 60395988
201, No. 39, Longfeng Road, XinsheSE DECISION MADE: 25-APR-23
Shenzhen CN 518116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MR DWI/FLAIR Measurement V1.0
Olea Medical 510(k) NO: K230552(Traditional)
ATTN: Nathalie Palumbo PHONE NO : 33 4 42712420
93 Avenue des Sorbiers, ZI ATHELIASE DECISION MADE: 26-APR-23
La Ciotat FR 13600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LINQ II Insertable Cardiac Monitor, CareLink SmartSync LINQ II ICM Application
Medtronic, Inc. 510(k) NO: K230553(Traditional)
ATTN: Kerry Luyster PHONE NO : 763 5052128
8200 Coral Sea Street NE SE DECISION MADE: 26-APR-23
Mounds View MN 55112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HILINE™ Fixation System
Globus Medical Inc. 510(k) NO: K230565(Traditional)
ATTN: Jennifer Antonacci PHONE NO : 610 9301800 1861
2560 General Armistead Ave. SE DECISION MADE: 20-APR-23
Audubon PA 19403 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FiberTak Suture Anchor
Arthrex Inc. 510(k) NO: K230568(Special)
ATTN: Erikka Edwardsen PHONE NO : 1 239 6435553 70422
1370 Creekside Boulevard SE DECISION MADE: 01-APR-23
Naples FL 34108-1945 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Limbus Contour
Limbus AI Inc. 510(k) NO: K230575(Special)
ATTN: Jon Giambattista PHONE NO : 1 306 5025982
2375 College Ave SE DECISION MADE: 07-APR-23
Regina CA S4P0S8 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Tigereye ST CTO-Crossing Catheter
Avinger, Inc. 510(k) NO: K230594(Traditional)
ATTN: Thomas Lawson PHONE NO : 510 2061794
400 Chesapeake Drive SE DECISION MADE: 25-APR-23
Redwood City CA 94063 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Aduro Comb (Model: SZ-22, SZ-22A, SZ-22B)
Light Tree Ventures Europe B.V. 510(k) NO: K230597(Traditional)
ATTN: Alain Dijkstra PHONE NO : 86 135 10378748
40A Fuxin Road, Fuyong SubdistrictSE DECISION MADE: 28-APR-23
Hague NL 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400 Series Digital SPECT/CT System (VERITON CT 416/464)
Spectrum Dynamics Medical Ltd 510(k) NO: K230600(Abbreviated)
ATTN: Igor Naroditsky PHONE NO : 972 54 4384386
22 Bareket St. North Industrial PaSE DECISION MADE: 28-APR-23
Caesarea IL 3079837 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Affinity Fusion™ Oxygenator System
Medtronic Inc. 510(k) NO: K230640(Special)
ATTN: Aj Thakkar PHONE NO : 508 4524897
7611 Northland Drive SE DECISION MADE: 06-APR-23
Minneapolis MN 55428 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SKOUT® system
Iterative Scopes Inc. 510(k) NO: K230658(Special)
ATTN: Dennis Francoeur PHONE NO : 603 8198397
675 Massachusetts Ave 2nd Floor SE DECISION MADE: 07-APR-23
Cambridge MA 02139 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AutoContour Model RADAC V3
Radformation, Inc. 510(k) NO: K230685(Special)
ATTN: Kurt Sysock PHONE NO : 844 7233675
335 Madison Avenue, 4th floor SE DECISION MADE: 14-APR-23
New York NY 10017 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: T-FIX™ 3DSI Joint Fusion System
Cutting Edge Spine, LLC 510(k) NO: K230689(Special)
ATTN: Kyle Kuntz PHONE NO : 704 2430892
6012 Waxhaw Hwy SE DECISION MADE: 05-APR-23
Mineral Springs NC 28108 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NaviCam Xpress Stomach System, NaviCam Xpress System
AnX Robotica Corp. 510(k) NO: K230694(Special)
ATTN: Cathlena Martinez PHONE NO : 859 8018517
6010 W Spring Creek Pkwy SE DECISION MADE: 13-APR-23
Plano TX 75024 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: APRO 70 Catheter and Alembic Aspiration Tubing
Alembic, LLC 510(k) NO: K230695(Special)
ATTN: Lisa Yen PHONE NO : 1 650 3885087
627 National Ave. SE DECISION MADE: 10-APR-23
Mountain View CA 94043 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Anivia SG1000 Pump Console
AMPTD Inc. 510(k) NO: K230698(Special)
ATTN: John Sasso PHONE NO : 781 9626274
226 Lowell Street, Unit B16 SE DECISION MADE: 18-APR-23
Wilmington MA 01887 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARIA Radiation Therapy Management (v18.0)
Varian Medical Systems Inc. 510(k) NO: K230699(Special)
ATTN: Peter J. Coronado PHONE NO : 1 650 4246320
3100 Hansen Way SE DECISION MADE: 10-APR-23
Palo Alto CA 94304 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RAIN Sheath™ Tibial Pedal Introducer
Cordis US Corp. 510(k) NO: K230704(Traditional)
ATTN: Wai Morgan PHONE NO : 704 5765147
14201 North West 60th Avenue SE DECISION MADE: 24-APR-23
Miami Lakes FL 33014 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POT PTCA Balloon Dilatation Catheter
BrosMed Medical Co., Ltd. 510(k) NO: K230705(Special)
ATTN: Crystal Lee PHONE NO : 86 769 22892018
15th Building, SMEs Venture Park, SE DECISION MADE: 11-APR-23
Dongguan CN 523808 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOFIRE® SPOTFIRE® Respiratory (R) Panel Mini
Biofire Diagnostics, LLC 510(k) NO: K230719(Special)
ATTN: Kevin Bourzac PHONE NO : 801 7366354
515 Colorow Drive SE DECISION MADE: 13-APR-23
Salt Lake City UT 84108 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Eagle S/Saevo Slim/D700 Slim
Alliage S/A Industrias Medica Odon510(k) NO: K230732(Third Party - Traditional)
ATTN: Daniel Camargo PHONE NO : 55 16 35121212
Rod. Abrão Assed, Km 53+450m SE DECISION MADE: 11-APR-23
Recreio Anhanguera BR 49935 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: TriMed Threaded Intramedullary Nail System
TriMed, Inc. 510(k) NO: K230749(Special)
ATTN: David Medoff PHONE NO : 661 2557406
27533 Avenue Hopkins SE DECISION MADE: 17-APR-23
Santa Clarita CA 91355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RCT800
Ray Co., Ltd. 510(k) NO: K230753(Special)
ATTN: Changhwan Lee PHONE NO : 82 605 1000
1F~3F, 4F(Part), 5F, 265, Daeji-RoSE DECISION MADE: 11-APR-23
Yongin-si KR 16882 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: L12 LED Light Source with AIM
Stryker 510(k) NO: K230754(Special)
ATTN: April Malmborg PHONE NO : 408 7542473
5900 Optical Court SE DECISION MADE: 11-APR-23
San Jose CA 95138 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OsteoCentric Integrated Hip Fastener System
OsteoCentric Technologies 510(k) NO: K230764(Special)
ATTN: Todd Evans PHONE NO : 1 800 9690639
75 West 300 North Suite 150 SE DECISION MADE: 18-APR-23
Logan UT 84321 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Altus Spine Monaco Pedicle Screw System
Altus Spine 510(k) NO: K230766(Special)
ATTN: Rand Baker PHONE NO : 302 2966767
1340 Enterprise Drive SE DECISION MADE: 19-APR-23
West Chester PA 19380 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Quantib Prostate
Quantib BV 510(k) NO: K230772(Special)
ATTN: Floor van Leeuwen PHONE NO : 31 108 411749
Westblaak 130 SE DECISION MADE: 17-APR-23
Rotterdam NL 3012 KM 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Anatase Spine Surgery Navigation System
Remex Medical Corp. 510(k) NO: K230783(Special)
ATTN: Wang Cheng-Hsiung PHONE NO : 88 642 3595336
4F., No. 9, Jingke Road, Nantun DiSE DECISION MADE: 21-APR-23
Taichung City TW 408209 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Precision1, Precision1 for Astigmatism
Alcon Laboratories, Inc. 510(k) NO: K230785(Special)
ATTN: Sherri Lakota PHONE NO : 18 176 155472
6201 South Freeway SE DECISION MADE: 20-APR-23
Fort Worth TX 76134-2099 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Knee+
Pixee Medical 510(k) NO: K230789(Special)
ATTN: Lucie Pécheur PHONE NO : 33 458 101365
14 rue Alain Savary SE DECISION MADE: 21-APR-23
Besancon FR 25000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Deep Learning Image Reconstruction
GE Healthcare Japan Corporation 510(k) NO: K230807(Special)
ATTN: He Haibo PHONE NO : 86 010 57083413
7-127, 4-chome, Asahigaoka SE DECISION MADE: 20-APR-23
Hino JP 191-8503 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PEEK SA Anterior Lumbar Interbody Fusion (ALIF) System
Kyocera Medical Technologies, Inc.510(k) NO: K230808(Special)
ATTN: Scott Rucker PHONE NO : 909 557 2360
1200 California Street Suite 210 SE DECISION MADE: 21-APR-23
Redlands CA 92374 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Digital Intraoral X-Ray Sensor
iRay Imaging Technology (Haining) 510(k) NO: K230811(Special)
ATTN: Jeffrey Wu PHONE NO : 86 0512 53690872
No. 2, Caohejing RD., Haining 3144SE DECISION MADE: 21-APR-23
Haining CN 314499 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Intense Pulsed Light Treatment System
Shangdong Huamei Technology Co., L510(k) NO: K230816(Special)
ATTN: Yugui Dong PHONE NO : 86 153 06469955
No. 588, Changning Street, High-teSE DECISION MADE: 21-APR-23
Weifang CN 261205 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OmniGuide RFID Surgical Laser Fibers
Omni-Guide Holdings, Inc. 510(k) NO: K230819(Special)
ATTN: Carlos O Acosta PHONE NO : 617 5514421
43 Manning Road SE DECISION MADE: 21-APR-23
Billerica MA 01821 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SofWave System
Sofwave Medical Ltd 510(k) NO: K230820(Special)
ATTN: Ruthie Amir PHONE NO : 972 54 3003164
1 Ha-Otsma St., SE DECISION MADE: 18-APR-23
Yokneam Illit IL 2069200 / 157 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TENS7000 Rechargeable (Model:TENS7000 Rechargeable)
Chongqing Rob Linka Science And Te510(k) NO: K230829(Third Party - Traditional)
ATTN: Yixuan Li PHONE NO : 86 199 36020574
B3-2, Liangjiang Health Science AnSE DECISION MADE: 26-APR-23
Chongqing CN 400700 510(k) STATEMENT
THIRD PARTY REVIEW
DEVICE: Identity Imprint Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate Sacrificing (CS) Insert
Conformis Inc. 510(k) NO: K230844(Special)
ATTN: Mary Kruitwagen PHONE NO : 781 3459038
600 Technology Park Drive Fourth FSE DECISION MADE: 27-APR-23
Billerica MA 01821 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 32HL512D, 31HN713D, 32HQ713D
LG Electronics Inc. 510(k) NO: K230845(Special)
ATTN: Jinhwan Jun PHONE NO : 82 31 80665641
168, Suchul-daero SE DECISION MADE: 27-APR-23
Gumi-si KR 39368 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPOTFIRE® RSP Pos & Neg Controls, SPOTFIRE® RSP Positive Control, SPOTFIRE® RSP Negative Control
Maine Molecular Quality Controls, 510(k) NO: K230868(Special)
ATTN: Joan Gordon PHONE NO : 207 8851072
23 Mill Brook Road SE DECISION MADE: 13-APR-23
Saco ME 04072 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Konicaminolta DI-X1
Konica Minolta, Inc. 510(k) NO: K230906(Special)
ATTN: Tsutomu Fukui PHONE NO : 81 42 5898429
1 Sakura-machi Hino-shi SE DECISION MADE: 25-APR-23
Tokyo JP 1918511 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Hand Trauma Threaded Nail System
Skeletal Dynamics, Inc. 510(k) NO: K230908(Special)
ATTN: Alexandra Rodriguez Rojas PHONE NO : 305 5967585
7300 North Kendall Drive Suite 400SE DECISION MADE: 28-APR-23
Miami FL 33156 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Braun Skin i.expert
CyDen Limited 510(k) NO: K230911(Special)
ATTN: Adam Stephens PHONE NO : 44 0179 2274009
Block A, Bay Studios Business ParkSE DECISION MADE: 27-APR-23
Swansea GB SA1 8QB 510(k) STATEMENT
DEVICE: Ingenia Elition and MR 7700 MR Systems
Philips Medical Systems, Nederland510(k) NO: K230972(Special)
ATTN: Ioana Ulea PHONE NO : 31 618 345875
Veenpluis 4-6 SE DECISION MADE: 28-APR-23
Best NL 5684 PC 510(k) SUMMARY AVAILABLE FROM FDA
TOTAL 510(k)s THIS PERIOD 231
TOTAL WITH SUMMARIES 220
TOTAL WITH STATEMENTS 11
