510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD June 2023
DEVICE: Tisuthes e-PTFE Surgical Patch
Shanghai Suokang Medical Implants 510(k) NO: K201153(Traditional)
ATTN: Lixinhua Lixinhua PHONE NO : 86 216608 2766 812
Building 2, No. 613, Suide Rd., PuSE DECISION MADE: 13-JUN-23
Shanghai CN 200000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: e-Celsius Medical System
BodyCAP 510(k) NO: K210924(Traditional)
ATTN: Sébastien Moussay PHONE NO : 33 261 530329
3 Dr. Laennec Street SE DECISION MADE: 28-JUN-23
Herouville Saint Clair FR 14200 510(k) STATEMENT
DEVICE: Fluido Compact Blood and Fluid Warming System
The Surgical Company International510(k) NO: K211618(Traditional)
ATTN: Inette Nieveen PHONE NO : 0031 33 4507250___
Beeldschermweg 6F SE DECISION MADE: 05-JUN-23
Amersfoort NL 3821 AH 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STA R Max 3, STA Compact Max 3
Diagnostica Stago SAS 510(k) NO: K212183(Traditional)
ATTN: Pauline Vasselon PHONE NO : 33 146 882378
3 allée Thérésa SE DECISION MADE: 07-JUN-23
Asniéres sur Seine FR 92600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ulspira TS Nitric Oxide Therapy System
Airgas Therapeutics 510(k) NO: K212409(Traditional)
ATTN: Steven Miller PHONE NO : 979 2855019
12800 West Little York Road SE DECISION MADE: 30-JUN-23
Houston TX 77041 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Diode laser therapy device
Beijing Star New Tech Co., Ltd. 510(k) NO: K212733(Traditional)
ATTN: Liang ZhongDong PHONE NO : 86 10 61271282
Room 618, Block C, Jinri Science PSE DECISION MADE: 06-JUN-23
Beijing CN 102600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Diode laser therapy device
TRIANGEL RSD LIMITED 510(k) NO: K212734(Traditional)
ATTN: Zhao Fengdan PHONE NO : 86 86 1893127322
Center Building 4, C Unit 324, #30SE DECISION MADE: 06-JUN-23
Baoding CN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AceConnex Pre-Sutured Fascia
AlloSource 510(k) NO: K213046(Traditional)
ATTN: Trevor Wright PHONE NO : 720 8730213
6278 S. Troy Circle SE DECISION MADE: 27-JUN-23
Centennial CO 80111 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Pixyl.Neuro
Pixyl SA 510(k) NO: K213253(Traditional)
ATTN: Senan Doyle PHONE NO : 33 9 72633068
5 Avenue du Grand Sablon SE DECISION MADE: 30-JUN-23
La Tronche FR 38700 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Fenom Pro
CAIRE Diagnostics Inc. 510(k) NO: K213611(Traditional)
ATTN: Ryan Leard PHONE NO : 925 4330725
7020 Koll Center Parkway Suite 110SE DECISION MADE: 07-JUN-23
Pleasanton CA 94566 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cresilon Hemostatic Gel, CHG, Cresilon Hemostatic Gel (CHG)
Cresilon, Inc. 510(k) NO: K213652(Traditional)
ATTN: Hassaan W. Ahmad PHONE NO : 347 4352226 103
87 35th Street, Suite 603/604 SE DECISION MADE: 28-JUN-23
Brooklyn NY 11232 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SpiroHome Personal, SpiroHome Clinic
Inofab Saglik Teknolojileri A.S 510(k) NO: K213754(Traditional)
ATTN: Deniz Sarp PHONE NO : 90 312 9880308
ODTU Teknokent, Silikon Blok 17/11SE DECISION MADE: 12-JUN-23
Cankaya, Ankara TR 06800 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AlloX2 Pro Tissue Expanders
Sientra, Inc. 510(k) NO: K214124(Traditional)
ATTN: Denise Daljes PHONE NO : 805 8796171
420 South Fairview Avenue Suite 20SE DECISION MADE: 08-JUN-23
Santa Barbara CA 93117 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sinobot X1
Sinovation (Beijing) Medical Techn510(k) NO: K220072(Traditional)
ATTN: Manman Xu PHONE NO :
Rm 401, Bld 12-1, No.26 Yongwang WSE DECISION MADE: 18-JUN-23
Beijing CN 102600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Mindray SV600 Ventilator, Mindray SV800 Ventilator
Shenzhen Mindray Bio-medical Elect510(k) NO: K220107(Traditional)
ATTN: Yanhong Bai PHONE NO : 86 755 81888998
Mindray Building, Keji 12th Road SSE DECISION MADE: 16-JUN-23
Shenzhen CN 518057 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARC Intensive Care Information System (ARC System)
Ordinatrum Solutions 510(k) NO: K220117(Traditional)
ATTN: Ali Yasin Ozturk PHONE NO : 858 5377065
2522 Chambers Rd Ste 216 SE DECISION MADE: 06-JUN-23
Tustin CA 92780 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Medi Lift PLUS
YA-MAN Ltd 510(k) NO: K220198(Traditional)
ATTN: Jun Takada PHONE NO : 81 3 56657321
2-4-2 Toyo SE DECISION MADE: 28-JUN-23
Koto-ku JP 1350016 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Volumat Line
Fresenius Kabi 510(k) NO: K220301(Traditional)
ATTN: Keith Dunn PHONE NO : 224 8172430
5 Robert-Koch-Strasse SE DECISION MADE: 02-JUN-23
Bad Hersfeld DE 3D-6251 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NovoGen Wound Matrix
Novabone Products, LLC 510(k) NO: K220498(Traditional)
ATTN: Ed Horton PHONE NO : 386 4627660 702
13510 NW US Highway 441 SE DECISION MADE: 09-JUN-23
Alachua FL 32615 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: F&P 950 Respiratory Humidifier
Fisher & Paykel Healthcare 510(k) NO: K220703(Traditional)
ATTN: Reena Daken PHONE NO : 64 9574 0100
15 Maurice Paykel Place SE DECISION MADE: 16-JUN-23
Auckland NZ 2013 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: vWF Ag
Siemens Healthcare Diagnostics Pro510(k) NO: K220728(Traditional)
ATTN: Petra Dissmann PHONE NO : 49 172 3692459
Emil-von-Behring Strasse 76 SE DECISION MADE: 02-JUN-23
Marburg DE 35041 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: The iNAP One Sleep Therapy System
Somnics Inc. 510(k) NO: K220907(Traditional)
ATTN: Chung-Chu Chen PHONE NO : 886 3 5509623
5F, N0. 22, 5F, No. 22, Sec. 2, ShSE DECISION MADE: 16-JUN-23
Hsinchu County TW 30261 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Hudson RCI Variable concentration Large Volume Nebulizer (1770)
Medline Industires, Inc. 510(k) NO: K220955(Traditional)
ATTN: Nicole Schaffer PHONE NO : 724 6409680
1 Three Lakes Drive SE DECISION MADE: 23-JUN-23
Northfield IL 60093 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: tremoflo C2 Airwave Oscillometry System
Thorasys Thoracic Medical Systems,510(k) NO: K221024(Traditional)
ATTN: Paul Donnelly PHONE NO : 514 4047709
6560 Avenue de l'Esplanade Suite #SE DECISION MADE: 20-JUN-23
Montreal CA H2V 4L5 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Volumat Polyethylene I.V. Administration Set
Fresenius Kabi 510(k) NO: K221121(Traditional)
ATTN: Jason Ma PHONE NO : 224 817 4100
5 Robert-Koch-Strasse SE DECISION MADE: 16-JUN-23
Bad Hersfeld DE 3D-6251 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: preCARDIA Occlusion System
Abiomed Inc. 510(k) NO: K221294(Traditional)
ATTN: Ken Ryder PHONE NO : 978___ 6461400 1607
22 Cherry Hill Drive SE DECISION MADE: 30-JUN-23
Danvers MA 01923 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Antibacterial Bandage
Winner Medical Co., Ltd. 510(k) NO: K221311(Traditional)
ATTN: Yi Fu PHONE NO : 86 755 28138888 8717
Winner Industrial Park, No. 660 BuSE DECISION MADE: 21-JUN-23
Shenzhen CN 518109 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Surflo Winged Infusion Set
Terumo Medical Products (Hangzhou)510(k) NO: K221411(Traditional)
ATTN: Brian Byrd PHONE NO : 908 2085226
M4-9-5, Economic & Technological DSE DECISION MADE: 23-JUN-23
Hangzhou CN 310018 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: F&P 950 Accessory Breathing Circuit Kits
Fisher & Paykel Healthcare Ltd 510(k) NO: K221436(Traditional)
ATTN: Reena Daken PHONE NO : 64 574 0100
15 Maurice Paykel Place, East TamaSE DECISION MADE: 29-JUN-23
Auckland NZ 2013 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Z7 Zirconia Implant System
Z7 LLC 510(k) NO: K221488(Traditional)
ATTN: Gerald Andrew Kaminsky PHONE NO : 908 3991359
28 Felmley Road SE DECISION MADE: 26-JUN-23
Whitehouse Station NJ 08889 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Synexis Sphere Rx
Synexis, LLC 510(k) NO: K221540(Traditional)
ATTN: Athena Hansen PHONE NO : 816 2939003
11711 W. 79th Street SE DECISION MADE: 14-JUN-23
Lenexa KS 66214 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Stella
Shinhung MST CO., LTD. 510(k) NO: K221752(Traditional)
ATTN: Sun Ho Lee PHONE NO : 82 33 7301901
110-2 Donghwagongdan-ro, Munmak-euSE DECISION MADE: 04-JUN-23
Wonju-si KR 26365 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ADVIA Centaur® Anti-Müllerian Hormone (AMH)
Siemens Healthcare Diagnostics Inc510(k) NO: K221801(Traditional)
ATTN: Mey Vasquez PHONE NO : 862 2138409
511 Benedict Avenue SE DECISION MADE: 02-JUN-23
Tarrytown NY 10591-5097 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Mais Central Venous Catheter
Saudi Mais Co. for Medical Product510(k) NO: K221827(Traditional)
ATTN: Salman Rashid PHONE NO : 00966 112650 184222
256 Third Industrial Area SE DECISION MADE: 23-JUN-23
Riyadh SA 14335-7599 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Genadyne Hybrid Foam Dressings
Genadyne Biotechnologies, Inc. 510(k) NO: K221888(Traditional)
ATTN: Saiken Ho PHONE NO : 516 4878787 118___
16 Midland Ave SE DECISION MADE: 12-JUN-23
Hicksville NY 11801 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Irreversible Electroporation Ablation Generator, Irreversible Electroporation Probe
Zhejiang CuraWay Medical Technolog510(k) NO: K222001(Traditional)
ATTN: Xiaoyu Guan PHONE NO :
Building 1, No.600, 21st street, QSE DECISION MADE: 08-JUN-23
Hangzhou CN 310018 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Breathe+
PEEP Medical LLC dba GO2 Devices 510(k) NO: K222018(Traditional)
ATTN: Paul Dryden PHONE NO : 239 3076061
9230 Katy Freeway, Suite 600 SE DECISION MADE: 02-JUN-23
Houston TX 77055 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BR SLA Type Implant System
Biotem Co., Ltd. 510(k) NO: K222142(Traditional)
ATTN: Hong Koo Yeo PHONE NO : 82 51 9088257
57, Sasang-ro, 401 beon-gil, SasanSE DECISION MADE: 24-JUN-23
Busan KR 46925 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IR SLA Type Implant System
Biotem Co., Ltd. 510(k) NO: K222144(Traditional)
ATTN: Hong Koo Yeo PHONE NO : 82 51 9088257
57, Sasang-ro, 410 beon-gil, SasanSE DECISION MADE: 14-JUN-23
Busan KR 46925 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Infrared Thermometer
Alicn Medical Shenzhen, Inc 510(k) NO: K222248(Traditional)
ATTN: Fang Meisong PHONE NO : 86 755 26501548
Room 410, Building A, 3rd Sub-parkSE DECISION MADE: 07-JUN-23
Shenzhen CN 518118 510(k) STATEMENT
DEVICE: Black Diamond
Elevate Oral Care, LLC 510(k) NO: K222323(Traditional)
ATTN: Steve Pardue PHONE NO : 877 8669113
346 Pike Rd, Suite 5 SE DECISION MADE: 23-JUN-23
West Palm Beach FL 33411 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITEK 2 AST-Gram Negative Levofloxacin (/=8 ug/mL)
bioMerieux, Inc. 510(k) NO: K222378(Traditional)
ATTN: Esther Hernandez PHONE NO : 314 7318841
595 Anglum Road SE DECISION MADE: 26-JUN-23
Hazelwood MO 63042 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LVIS NeuroMatch
LVIS Corporation 510(k) NO: K222450(Traditional)
ATTN: William Antilla PHONE NO : 415 9977337
2600 East Bayshore Rd. SE DECISION MADE: 09-JUN-23
Palo Alto CA 94303 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AirTom
Bilab 510(k) NO: K222466(Traditional)
ATTN: Sang Keun Lee PHONE NO : 82 70 48650502
5F Ubiquoss Building, 68 Pangyo-roSE DECISION MADE: 30-JUN-23
Seongnam-si KR 13486 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Hope&Her Vaginal Dilators
Lujena, Inc. 510(k) NO: K222492(Traditional)
ATTN: Troy Gemmer PHONE NO : 808___ 4638796
772 Jamacha Rd., #800 SE DECISION MADE: 27-JUN-23
El Cajon CA 92019 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AltiVate® Anatomic Shoulder AG e+™ with Markers
Encore Medical, L.P 510(k) NO: K222592(Abbreviated)
ATTN: Michael Siano PHONE NO : 512 7814219
9800 Metric Blvd SE DECISION MADE: 23-JUN-23
Austin TX 78758 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BabySat 3
Owlet Baby Care, Inc. 510(k) NO: K222597(Traditional)
ATTN: Tammy Lavery PHONE NO : 801 9317736
3300 Ashton Blvd. Suite 300 SE DECISION MADE: 16-JUN-23
Lehi UT 84043 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Accurate 24 Non-invasive blood pressure monitor
Accurate Meditech Inc. 510(k) NO: K222658(Traditional)
ATTN: Wang Kuan Jen PHONE NO : 886 2 29991596
8F-10, No. 12, Lane 609, Sec. 5, CSE DECISION MADE: 21-JUN-23
New Taipei City TW 241406 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato® Spinal System, XIA® Growth Rod Conversion Set, XIA® II Spinal System, XIA® Precision System, XIA® Anterior, Diapason® Spinal System, Opus™ Spinal System, Radius® Spinal System, Mantis® Spinal System, Mantis® Redux, Trio® & Trio+ Spinal Fixation System, ES2™ Spinal System, ES2™ Augmentable Spinal System, Oasys® Occipito-Cervico-Thoracic System, Nile® Proximal Fixation Spinal System, Nile® Alternative Fixation Spinal System, and Escalate® Laminoplasty System
Stryker Spine 510(k) NO: K222684(Traditional)
ATTN: Sierra Mertz PHONE NO : 484 4088221 ______
2 Pearl Court SE DECISION MADE: 08-JUN-23
Allendale NJ 07401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RGS; RGS Mini
Genesis Air, Inc. 510(k) NO: K222702(Traditional)
ATTN: Dan Briggs PHONE NO : 807 7457000
5202 County Road 7350, Suite D SE DECISION MADE: 02-JUN-23
Lubbock TX 79424 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: i3 ONE (203100-S);i3 TWO connect (203200-S);i3 TWO direct (203300-S)
i3 Membrane GmbH 510(k) NO: K222727(Traditional)
ATTN: Stephan Brinke-Seiferth PHONE NO : 004 94025 7674810
Christoph-Seydel-Strasse 1 SE DECISION MADE: 02-JUN-23
Radeberg DE 01454 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SIDDHARTH-II;IMPACT
Panacea Medical Technologies Pvt L510(k) NO: K222762(Traditional)
ATTN: Valli G. PHONE NO : 91 934 3779160___
Plot No. 35, 4th Phase, Malur KIADSE DECISION MADE: 08-JUN-23
Malur IN 563130 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: F65 Laser System
Lumenis Be, Ltd. 510(k) NO: K222790(Traditional)
ATTN: Shlomit Segman PHONE NO : 972 4 9599085
6 Hakidma Street PO BOX 240 SE DECISION MADE: 14-JUN-23
Yokneam IL 2069204 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SNUCONE Tissue Level Implant System
Snucone Co., Ltd. 510(k) NO: K222792(Traditional)
ATTN: Song Ha Eun PHONE NO : 82 53 5927525
5, Seongseo-ro 75-gil SE DECISION MADE: 08-JUN-23
Dalseo-gu KR 42703 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VentStar Helix dual heated (N) Plus (MP02650), VentStar Helix heated (N) Plus (MP02608)
Draegerwerk AG & Co. KGaA 510(k) NO: K222822(Traditional)
ATTN: Jan Upmeier PHONE NO : 49 451 8828474
Moislinger Allee 53-55 SE DECISION MADE: 14-JUN-23
Luebeck DE 23542 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EVIS XI Video System Center Olympus CV-1500, Bronchovideoscope Olympus BF-H1100, Bronchovideoscope Olympus BF-1TH1100
Olympus Medical Systems Corporatio510(k) NO: K222861(Traditional)
ATTN: Shinichiro Kawachi PHONE NO : 81 42 6422694
2951 Ishikawa-cho Hachioji-shi SE DECISION MADE: 15-JUN-23
Tokyo JP 192-8507 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Maxcon Sharps Container (1 QT Sharps Container, MA1112), Maxcon Sharps Container (5.4 QT Sharps Container, MA1212), Maxcon Sharps Container (5.4 QT Sharps Container, MA1213), Maxcon Sharps Container (7 Liter Sharps Container, MA1324)
Ningbo Maxcon Medical Technology C510(k) NO: K222905(Traditional)
ATTN: Puhai Ma PHONE NO :
No.228 Dongxin Road, Dongqiao TownSE DECISION MADE: 01-JUN-23
Ningbo CN 315000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Maxcon Reusable Sharps Container, 17 Gallon Sharps Container MA1421
Ningbo Maxcon Medical Technology C510(k) NO: K222906(Traditional)
ATTN: Puhai Ma PHONE NO :
No.228 Dongxin Road, Dongqiao TownSE DECISION MADE: 16-JUN-23
Ningbo CN 315000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INVOcell Intravaginal Culture System
INVO Bioscience 510(k) NO: K222932(Traditional)
ATTN: Steve Shum PHONE NO : 415 6526387___
5582 Broadcast Court SE DECISION MADE: 22-JUN-23
Sarasota FL 34240 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MYAH
VISIA Imaging S.r.l. 510(k) NO: K222933(Traditional)
ATTN: Alessia Magnanini PHONE NO : 39 055 9121635
Via Martiri della Libertà 95/e SE DECISION MADE: 29-JUN-23
San Giovanni Valdarno IT 52027 510(k) STATEMENT
DEVICE: Harvest Conceal ZR Block Out
Harvest Dental Products, LLC 510(k) NO: K222961(Traditional)
ATTN: Colleen Boswell PHONE NO : 714 5853431
905 Columbia Street SE DECISION MADE: 02-JUN-23
Brea CA 92821 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FERTI-LILY Conception Cup
Rosesta Medical BV 510(k) NO: K222969(Traditional)
ATTN: Stal Robert PHONE NO : 31 208 086020
Mr. Treublaan 7 I SE DECISION MADE: 23-JUN-23
Amsterdam NL 1079DP 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Virtus Metabolic Monitor
Virtus Technology ApS 510(k) NO: K222982(Traditional)
ATTN: Leif Olesen PHONE NO : 455 230 3833______
Svalevej 4 SE DECISION MADE: 23-JUN-23
Roennede DK DK-4683 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: F3
Acrew Imaging, Inc. 510(k) NO: K222998(Traditional)
ATTN: Craig Hughes PHONE NO : 713 2534542
38852 Cedar Waxwing Lane SE DECISION MADE: 20-JUN-23
Ocean View DE 19970 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Surgical Gown
Hubei Woozon Healthcare Co.,Ltd. 510(k) NO: K222999(Traditional)
ATTN: Li Chunlin PHONE NO : 86 728 3280667
Nongfeng Road, Nonwoven Fabric IndSE DECISION MADE: 16-JUN-23
Xiantao City CN 433018 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AccurECG Analysis System
AccurKardia, Inc. 510(k) NO: K223013(Traditional)
ATTN: Juan C. Jimenez PHONE NO : 804 5394603
101 Avenue of Americas, Floor 8 SE DECISION MADE: 23-JUN-23
New York NY 10013 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: sam 2.0 Long Ultrasound Device
ZetrOZ Systems, LLC 510(k) NO: K223019(Traditional)
ATTN: Sabrina Lewis PHONE NO : 888 2029831
56 Quarry Road SE DECISION MADE: 23-JUN-23
Trumbull CT 06611 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Perfit CL
Vatech mcis Co., Ltd. 510(k) NO: K223029(Traditional)
ATTN: Kim Gyeong Rok PHONE NO : 82 31 80051855__
2544, Nambuk-daero, Idong-eup, CheSE DECISION MADE: 20-JUN-23
Yongin-si KR 17137 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Tixel® 2 System
Novoxel Ltd. 510(k) NO: K223033(Traditional)
ATTN: Omri Findler PHONE NO : 972 0528 313600
43 Hamelaha St. SE DECISION MADE: 21-JUN-23
Netanya IL 4250573 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NeuroSwift Pro
Neurobit Technologies Co., Ltd. 510(k) NO: K223047(Traditional)
ATTN: Chun-Chen Yang PHONE NO : 886 2 22710618
2F, No. 320 Sec 4, Zhongxiao E. RdSE DECISION MADE: 29-JUN-23
Taipei TW 10694 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Medisystem Pacs
Medilab Manutencao E Sitemas Ltda 510(k) NO: K223048(Traditional)
ATTN: Jorge Millan PHONE NO : 786 4165587
Rua Amaral, 80, Andarai SE DECISION MADE: 23-JUN-23
Rio De Janeiro BR 20541-155 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Xenco Medical InterAlign Cervical Interbody System
Xenco Medical, LLC 510(k) NO: K223059(Traditional)
ATTN: Jason Haider PHONE NO : 858 2021522 202
9930 Mesa Rim Rd SE DECISION MADE: 07-JUN-23
San Diego CA 92121-2910 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Niti-S Duodenal Stent; Niti-S Colonic Comfort Stent
Taewoong Medical Co., Ltd. 510(k) NO: K223067(Traditional)
ATTN: Yongjin Kim PHONE NO : 82 70 46491543
14 Gojeong-ro, Wolgot-myeon SE DECISION MADE: 14-JUN-23
Gimpo-si KR 10022 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CorNeat EverPatch
CorNeat Vision Ltd. 510(k) NO: K223074(Traditional)
ATTN: Gerry Tal PHONE NO : 972 52 3562826
4 Hasheyzaf St. SE DECISION MADE: 02-JUN-23
Raanana IL 4366411 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Atellica® CH Diazo Direct Bilirubin (D_DBil)
Siemens Healthcare Diagnostics Inc510(k) NO: K223078(Traditional)
ATTN: Anthony Calabro PHONE NO : 1 609 4336415___
500 GBC Drive, M/S 514, PO Box 610SE DECISION MADE: 12-JUN-23
Newark DE 19714 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Straumann SLActive labeling changes
Institut Straumann AG 510(k) NO: K223083(Traditional)
ATTN: Ana Vianna PHONE NO : 41 61 9651512
Peter Merian Weg 12 SE DECISION MADE: 22-JUN-23
Basel CH CH-4002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CT Perfusion V1.0
Olea Medical 510(k) NO: K223091(Traditional)
ATTN: Nathalie Palumbo PHONE NO : 33 4 42712420
93 Avenue des Sorbiers, ZI ATHELIASE DECISION MADE: 09-JUN-23
La Ciotat FR 13600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Hudson RCI AquaTherm III Plus External Adjustable Electronic Heater (050-14)
Medline Industries, Inc 510(k) NO: K223100(Traditional)
ATTN: Nichole Schaffer PHONE NO : 724 6409680 ______
1 Three Lake Drive SE DECISION MADE: 27-JUN-23
Northfiled IL 60093 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BethaLoc® stem cementless HA
implantcast Gmbh 510(k) NO: K223103(Traditional)
ATTN: Juliane Hoppner PHONE NO : 49 4161 7440
Lüneburger Schanze 26 SE DECISION MADE: 20-JUN-23
Buxtehude DE 21614 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AblatePal Radiofrequency Ablation System
Compal Electronics, Inc 510(k) NO: K223135(Traditional)
ATTN: Casper Chen PHONE NO : 886 287 9785916030
No. 581, Ruiguang Rd., Neihu DistrSE DECISION MADE: 30-JUN-23
Taipei City TW 11492 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AB1 Electrosurgical Instrument, Creo Electrosurgical System
Creo Medical Ltd. 510(k) NO: K223138(Traditional)
ATTN: Tiffany Powell PHONE NO : 44 0 7760150775
Creo House, Unit 2, Beaufort Park SE DECISION MADE: 26-JUN-23
Chepstow UA NP16 5UH 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SAGICO Spinal System
Sagico VA USA, LLC 510(k) NO: K223143(Traditional)
ATTN: James G Gibson PHONE NO : 813 8150613
2189 W.Busch Blvd SE DECISION MADE: 26-JUN-23
Tampa FL 33612 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Radixact Treatment Delivery System
Accuray Incorporated 510(k) NO: K223159(Traditional)
ATTN: Karla Fields PHONE NO : 608 8242990
1209 Deming Way SE DECISION MADE: 23-JUN-23
Madison WI 53717 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HemosIL Liquid Anti-Xa
Instrumentation Laboratory Co. 510(k) NO: K223187(Traditional)
ATTN: Carol Marble PHONE NO : 781 8614467
180 Hartwell Road SE DECISION MADE: 23-JUN-23
Bedford MA 01730 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Zynex Monitoring System, Model CM-1600
Zynex Medical, Inc. 510(k) NO: K223217(Traditional)
ATTN: Donald Gregg PHONE NO : 303 7099605
9655 Maroon Circle SE DECISION MADE: 16-JUN-23
Englewood CO 80112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Tablo® Hemodialysis System
Outset Medical, Inc. 510(k) NO: K223248(Traditional)
ATTN: Saket Bhatt PHONE NO : 408 7017319
3052 Orchard Drive SE DECISION MADE: 21-JUN-23
San Jose CA 95134 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TNI Clear-Guard™ 3 angled breathing filter (1545020)
Intersurgical Ltd. 510(k) NO: K223258(Traditional)
ATTN: Ivan Seniut PHONE NO : 370 37 01766611
Crane House Molly Millars Lane, WoSE DECISION MADE: 15-JUN-23
Berkshire GB RG41 2RZ 510(k) STATEMENT
DEVICE: Electronic Blood Pressure Monitor
Shenzhen Pango Medical Electronics510(k) NO: K223291(Traditional)
ATTN: Xiaoyun Yang PHONE NO : 86 755 33825989
No. 25, 1st Industry Zone, FenghuaSE DECISION MADE: 14-JUN-23
Shenzhen CN 518115 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ambu® aScope™ 5 Broncho HD 5.0/2.2, Ambu® aScope™ 5 Broncho HD 5.6/2.8, Ambu® aView™ 2 Advance
Ambu A/S 510(k) NO: K223299(Traditional)
ATTN: Magnus Lynge PHONE NO : 45 3024 2573
Baltorpbakken 13 SE DECISION MADE: 01-JUN-23
Ballerup DK 2750 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EyeArt v2.2.0
Eyenuk, Inc. 510(k) NO: K223357(Traditional)
ATTN: Kaushal Solanki PHONE NO : 818 8353585
5850 Canoga Ave, Suite 250 SE DECISION MADE: 16-JUN-23
Los Angeles CA 91367 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BMR 1900 PHISIO
Sorin Group Italia S.R.L. 510(k) NO: K223361(Traditional)
ATTN: Luigi Vecchi PHONE NO : 39 0535 29957_____
Via Statale 12 Nord, 86 SE DECISION MADE: 10-JUN-23
Mirandola IT 41037 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Blood Pressure Monitor
Guangdong Transtek Medical Electro510(k) NO: K223374(Traditional)
ATTN: Jerry Fan PHONE NO : 0086 136 86499705
Zone A, No.105, Dongli Road, TorchSE DECISION MADE: 30-JUN-23
Zhongshan CN 528437 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Monoject Magellan Insulin Safety Syringe 1mL, 31G x 6mm (8881893110); Monoject Magellan Insulin Safety Syringe 0.5mL, 31G x 6mm (8881893150); Monoject Magellan Insulin Safety Syringe 0.3mL, 31G x 6mm (8881893130)
Cardinal Health 200, LLC 510(k) NO: K223376(Abbreviated)
ATTN: Emily Hunter PHONE NO : 847 8876367
3651 Birchwood Drive SE DECISION MADE: 21-JUN-23
Waukegan IL 60085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Portable Oxygen Concentrator (Model: P2-E7, P2-E)
Qingdao Kingon Medical Science and510(k) NO: K223379(Traditional)
ATTN: Zhang Benrong PHONE NO : 86 185 65833539
Room 301-302, No.15 HanchengRoad SE DECISION MADE: 22-JUN-23
Qingdao Free Trade Zone CN 266555510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OmniTom Elite
NeuroLogica Corporation, a subsidi510(k) NO: K223447(Traditional)
ATTN: Ninad Gujar PHONE NO : 978 5648632
Electronics Co., Ltd 14 ElectronicSE DECISION MADE: 01-JUN-23
Danvers MA 01923 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WallFlex™ Biliary RX Stent System
Boston Scientific Corporation 510(k) NO: K223469(Traditional)
ATTN: Alexis Erazo PHONE NO : 508 3820365
100 Boston Scientific Way SE DECISION MADE: 15-JUN-23
Marlborough MA 01752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Radius VSM and Accessories
Masimo Corporation 510(k) NO: K223498(Traditional)
ATTN: Kertana Shankar PHONE NO : 949 2977260
52 Discovery SE DECISION MADE: 01-JUN-23
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Clear Aligner
Wuxi EA Medical Instruments Techno510(k) NO: K223517(Traditional)
ATTN: Jessica Luo PHONE NO : 86 0510 83591717 181
No.1619 Huishan Avenue, Huishan EcSE DECISION MADE: 13-JUN-23
Wuxi CN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: iOrtho
Shanghai EA Medical Instruments Co510(k) NO: K223518(Traditional)
ATTN: Jessica Luo PHONE NO : 86 0510 83591717 181
No.1619 Huishan Avenue, Huishan EcSE DECISION MADE: 13-JUN-23
Wuxi CN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NC° Thermometer (Gen 3), Model Number: NCTG3
Xiamen Intretech Inc. 510(k) NO: K223522(Traditional)
ATTN: Sunny Sun PHONE NO : 86 157 50706715
No.100, Dongfu West Road, Haicang SE DECISION MADE: 20-JUN-23
Xiamen CN 361000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Olea S.I.A. Neurovascular V1.0
Olea Medical 510(k) NO: K223532(Traditional)
ATTN: Nathalie Palumbo PHONE NO : 33 442 712420
93 Avenue des Sorbiers, ZI ATHELIASE DECISION MADE: 06-JUN-23
La Ciotat FR 13600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMARTbase Abutment System
Implant Direct Sybron Manufacturin510(k) NO: K223535(Traditional)
ATTN: Reina Choi PHONE NO : 818 3073132
3050 East Hillcrest Drive SE DECISION MADE: 20-JUN-23
Thousand Oaks CA 91362 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Brainomix 360 e-CTP
Brainomix Limited 510(k) NO: K223555(Traditional)
ATTN: Gwilym Owen PHONE NO : 440 1865 582730
First Floor, Seacourt Tower West WSE DECISION MADE: 01-JUN-23
Oxford GB OX2 7HN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DeepCatch
MEDICALIP Co., Ltd 510(k) NO: K223556(Traditional)
ATTN: Jun-sik Yoon PHONE NO : 82 22135 9148
SNUH Cancer Research Center 806, 1SE DECISION MADE: 16-JUN-23
Seoul KR 03080 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CUVIS-spine
Curexo, Inc. 510(k) NO: K223558(Traditional)
ATTN: Sujin Yang PHONE NO : 82 31 7887938
577, Gangnam-Daero, Seocho-Gu SE DECISION MADE: 22-JUN-23
Seoul KR 06530 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Xpan Universal Trocar System
Xpan Inc. 510(k) NO: K223562(Traditional)
ATTN: Zaid Atto PHONE NO : 647 6488921
57 Corstate Suite 200 SE DECISION MADE: 02-JUN-23
Vaughan CA L4K 4y2 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SQ.line KERRISON
Aesculap Inc. 510(k) NO: K223596(Traditional)
ATTN: Benjamin Oswald PHONE NO : 49 746 19531061
3773 Corporate Parkway SE DECISION MADE: 29-JUN-23
Center Valley PA 18034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Neodent Implant System - Helix Short Implant System
JJGC Industria e Comercio de Mater510(k) NO: K223638(Traditional)
ATTN: Barbara Uzae PHONE NO : 55 41 21694058
Av. Juscelino Kubitschek de OliveiSE DECISION MADE: 23-JUN-23
Curitiba BR 81270-200 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IB Lab LAMA
IB Lab GmbH 510(k) NO: K223646(Traditional)
ATTN: Richard Ljuhar PHONE NO : 43 699 16106712
Zehetnergasse 6/2/2 SE DECISION MADE: 16-JUN-23
Vienna AT 1140 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SecurePortIV Advanced Catheter Securement Adhesive
Adhezion Biomedical, LLC. 510(k) NO: K223669(Traditional)
ATTN: Richard Jones PHONE NO : 610 2958557
506 Pine Mountain Rd. SE DECISION MADE: 12-JUN-23
Hudson NC 28638 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SomniCheck
BrainMatterZ, LLC 510(k) NO: K223676(Traditional)
ATTN: Kevin Wilson PHONE NO : 469 8311161___
19830 FM 1093 SE DECISION MADE: 01-JUN-23
Richmond TX 77407 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Tinearity G1 (6103); Tinearity G1 Adapters x3 (6042)
Duearity AB 510(k) NO: K223694(Traditional)
ATTN: Anneli Johansson PHONE NO : 43 736 266354 ______
Krusegrand 42d SE DECISION MADE: 30-JUN-23
Malmo SE 21225 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Celerity Incubator
STERIS Corporation 510(k) NO: K223715(Traditional)
ATTN: Gregoy Land PHONE NO : 440 3927424
5960 Heisley Rd SE DECISION MADE: 15-JUN-23
Mentor OH 44060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Celerity 5 HP Biological Indicator; Celerity 5 HP Challenge Pack
STERIS Corporation 510(k) NO: K223717(Traditional)
ATTN: Gregory Land PHONE NO : 440 3927424
5960 Heisley Road SE DECISION MADE: 15-JUN-23
Mentor OH 44060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HandX™ Self-Righting Needle Holder
Human Xtensions Ltd. 510(k) NO: K223718(Traditional)
ATTN: Maija Wallenstein PHONE NO : 972 54 2053344
Meir Ariel 4 SE DECISION MADE: 05-JUN-23
Netanya IL 4250574 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MIO Blood Glucose Monitoring System
Mio Labs Inc. 510(k) NO: K223722(Traditional)
ATTN: Mark Qian PHONE NO : 1 301 9100529
#1023, ZGC Innovation Center, 4500SE DECISION MADE: 28-JUN-23
Santa Clara CA 95054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Pusen Single Use Flexible Video Cystoscope/Choledochoscope System (Single Use Flexible Video Cystoscope/Choledochoscope:PC200-AS, PC200-AR, PC200-S and PC200-R;HD Medical Video Endoscope Image Processor: PV300)
Zhuhai Pusen Medical Technology Co510(k) NO: K223741(Traditional)
ATTN: Changshen Wang PHONE NO : 086 7566 880865____
5/F, Building 1, No 33, Ke Ji San SE DECISION MADE: 22-JUN-23
Zhuhai CN 519085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FX V135(TM) Shoulder Prosthesis
FX Shoulder USA, Inc 510(k) NO: K223801(Traditional)
ATTN: Cory Trier PHONE NO : 800 2800775
13465 Midway Road, Suite 101 SE DECISION MADE: 05-JUN-23
Dallas TX 75244 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACTIVBRAID™
Embody, Inc. 510(k) NO: K223822(Traditional)
ATTN: Brianna Schehr PHONE NO : 236 9947912
4211 Monarch Way, Suite 500 SE DECISION MADE: 02-JUN-23
Norfolk VA 23508 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Unistik® ShieldLock, Unistik VacuFlip
Owen Mumford Ltd 510(k) NO: K223854(Traditional)
ATTN: Darren Mansell PHONE NO : 019 93 812021
Owen Mumford, Brook Hill, WoodstocSE DECISION MADE: 30-JUN-23
Woodstock GB OX20 ITU 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FEops HEARTguideTM, FEops HEARTguideTM ALPACA
FEops nv 510(k) NO: K223855(Traditional)
ATTN: Peter Mortier PHONE NO : 32 929 28030
Technologiepark 122 SE DECISION MADE: 06-JUN-23
Gent-Zwijnaarde BE 9052 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Assisted Fluid Management software feature with Acumen AFM Cable and Acumen IQ fluid meter, Pressure Controller, Heart Reference Sensor
Edwards Lifesciences, LLC 510(k) NO: K223865(Traditional)
ATTN: Sara Pesian PHONE NO : 949 2502232
One Edwards Way SE DECISION MADE: 09-JUN-23
Irvine CA 92614 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Miria Skin Treatment System
Avava, Inc. 510(k) NO: K223871(Traditional)
ATTN: Jay Bhawalkar, PhD PHONE NO : 617 3777945
275 Second Avenue, Floor 3 SE DECISION MADE: 22-JUN-23
Waltham MA 02451 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NAJA Gastrointestinal Catheter
Chess Medical Inc. 510(k) NO: K223890(Traditional)
ATTN: Dr. Yen-I Chen PHONE NO : 514 2913154
1650 Sherbrooke Street West, SuiteSE DECISION MADE: 16-JUN-23
Montreal CA H3H 1C9 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VINNO E20, VINNO E10,VINNO E10P,VINNO E10E, VINNO X1,VINNO X1E,VINNO X1P, VINNO X2,VINNO X2E,VINNO X2P
VINNO Technology (Suzhou) Co.,Ltd 510(k) NO: K223917(Traditional)
ATTN: Cordelia Liu PHONE NO : 86 512 62873806
5F Building A,4F Building C No. 27SE DECISION MADE: 17-JUN-23
Suzhou CN 215123 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AltaTrack Equipment R1.2, AltaTrack Guidewire, AltaTrack 3D Hub
Philips Medical Systems Nederland 510(k) NO: K223918(Abbreviated)
ATTN: Jeanette Becker PHONE NO : 31 6 21823383
Veenpluis 6 SE DECISION MADE: 08-JUN-23
Best NL 5684 PC 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VINNO G50, VINNO G55, VINNO M50, VINNO E30, VINNO X5, VINNO X6, VINNO X7, VINNO M55, VINNO E35, VINNO X65, VINNO X55, VINNO X35, VINNO G55E, VINNO G55P, VINNO M55E, VINNO M55P, VINNO E35E, VINNO E35P
VINNO Technology (Suzhou) Co.,Ltd 510(k) NO: K223920(Traditional)
ATTN: Cordelia Liu PHONE NO : 86 512 62873806
5F Building A,4F Building C No. 27SE DECISION MADE: 17-JUN-23
Suzhou CN 215123 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Laguna™ Clot Retriever System and Malibu™ Aspiration Catheter System (Laguna Thrombectomy System)
Innova Vascular, Inc. 510(k) NO: K223929(Traditional)
ATTN: Ryan Kenney PHONE NO : 512 3643830
15375 Barranca Parkway, B-101 SE DECISION MADE: 01-JUN-23
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Pantheris LV Atherectomy Catheter
Avinger, Inc. 510(k) NO: K230005(Traditional)
ATTN: Thomas Lawson PHONE NO : 510 2061794
400 Chesapeake Drive SE DECISION MADE: 06-JUN-23
Redwood City CA 94063 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ablamap® System
Ablacon, Inc. 510(k) NO: K230008(Traditional)
ATTN: Frank Rodrigues PHONE NO : 303 9555763
4800 Wadsworth Blvd. Suite 310 SE DECISION MADE: 08-JUN-23
Denver CO 80033 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OmniBone™ Bone Marrow Biopsy Kit with Power Driver, OmniBone™ Bone Biopsy Kit with Power Driver
Laurane Medical SAS 510(k) NO: K230015(Traditional)
ATTN: Laurent Fumex PHONE NO : 860 3999900___
Chemin de la bayette ZAC de la baySE DECISION MADE: 16-JUN-23
Le Pradet FR 83220 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Pre-Sutured Tendon (4561SC / Single Strand); Pre-Sutured Tendon (4564SC / Quadruple Strand )
RTI Surgical, Inc 510(k) NO: K230036(Traditional)
ATTN: Lynne Witkowski PHONE NO : 352 5388359
11621 Research Circle SE DECISION MADE: 23-JUN-23
Alachua FL 32615 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Inogen Rove 6
Inogen, Inc 510(k) NO: K230052(Traditional)
ATTN: Sandra LeClair PHONE NO : 315 8681202___
301 Coromar Drive SE DECISION MADE: 30-JUN-23
Goleta CA 93117 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Acumen Hypotension Prediction Index (HPI) Algorithm
Edwards Lifesciences LLC 510(k) NO: K230057(Traditional)
ATTN: Varad Raghuwanshi PHONE NO : 949 7564502
One Edwards Way SE DECISION MADE: 08-JUN-23
Irvine CA 92614 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3KVl-5K
Microlife Intellectual Property Gm510(k) NO: K230075(Traditional)
ATTN: Ariel Wang PHONE NO : 886 287 971288 366
Espenstrasse 139 SE DECISION MADE: 28-JUN-23
Widnau CH 9443 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CAC Software
Imbio, Inc. 510(k) NO: K230112(Traditional)
ATTN: Kay Sisavath PHONE NO : 978 7707005
1015 Glenwood Ave, Floor 4 SE DECISION MADE: 13-JUN-23
Minneapolis MN 55405 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 5F Launcher Guide Catheter, 6F Launcher Guide Catheter, 7F Launcher Guide Catheter, 8F Launcher Guide Catheter
Medtronic Vascular 510(k) NO: K230156(Special)
ATTN: Shalin Parikh PHONE NO : 1 978 7393047
37A Cherry Hill Drive SE DECISION MADE: 30-JUN-23
Danvers MA 01923 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VINNO G86,VINNO G86E,VINNO G65,VINNO G65P,VINNO G65E,VINNO G65D,VINNO M86, VINNO M86E,VINNO G90,VINNO G90E
Vinno Technology (Suzhou) Co., Ltd510(k) NO: K230160(Traditional)
ATTN: Cordelia Liu PHONE NO : 86 512 62873806
5F Building A, 4F Building C No. 2SE DECISION MADE: 23-JUN-23
Suzhou CN 215123 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Upper Arm Blood Pressure Monitor
Shenzhen Yolanda Technology Co., L510(k) NO: K230176(Traditional)
ATTN: Xuejun Wang PHONE NO : 86 755 21635022
Room 201,Jinfulai Building, No.49-SE DECISION MADE: 29-JUN-23
Shenzhen CN 518000 510(k) STATEMENT
DEVICE: ANT-X System
NDR Medical Technology Pte. Ltd. 510(k) NO: K230185(Abbreviated)
ATTN: Ng Ka Wei PHONE NO : 65 98 310731
75 Ayer Rajah Crescent, #02-19 SE DECISION MADE: 01-JUN-23
Singapore SG 139935 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Huma RPM (RPM)
Medopad Inc 510(k) NO: K230214(Traditional)
ATTN: Mani Shanmugham PHONE NO : 801 6739973___
The Genome Center 101 6th Avenue SE DECISION MADE: 02-JUN-23
New York NY 10013 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DynaFlex Clear Brackets & Buttons
Dyna Flex 510(k) NO: K230225(Traditional)
ATTN: Matthew Malabey PHONE NO : 314 4264020
8050 Hawk Ridge Trail SE DECISION MADE: 05-JUN-23
Lake Saint Louis MO 63367 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Gnesis EMS Plus
Creative Fitness Developments S.L.510(k) NO: K230261(Traditional)
ATTN: Jose Luis Delgado PHONE NO : 34 699 164244
Alfahuir, 40 SE DECISION MADE: 06-JUN-23
Valencia ES 46020 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TECHFIT DISRP® System
TECHFIT Digital Surgery 510(k) NO: K230276(Traditional)
ATTN: Angela María Lema-Pérez PHONE NO : 57 301 7922046___
1511 Aviation Center Pkwy Suite 22SE DECISION MADE: 23-JUN-23
Daytona Beach FL 32114 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TheraFace Mask
Therabody, Inc. 510(k) NO: K230293(Traditional)
ATTN: CJ Frederick, III PHONE NO : 484 8881290
6100 Wilshire Blvd, Suite 200 SE DECISION MADE: 09-JUN-23
Los Angeles CA 90048 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Intra-Operative Positioning System (IOPS®) (MC-1); IOPS Simple Curve Catheter (SCC-1) and IOPS Reverse Curve Catheter (RCC-1); IOPS Guidewire (ATW-2); IOPS Tracking Pad (TP-1); IOPS Guidewire Handle (SSH-1)
Centerline Biomedical, Inc. 510(k) NO: K230309(Special)
ATTN: Amanda Shade PHONE NO : 216 2067364
1000 Cedar Avenue SE DECISION MADE: 21-JUN-23
Cleveland OH 44106 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SelectFlex Neurovascular Access System Family
Q'apel Medical, Inc. 510(k) NO: K230322(Traditional)
ATTN: Kim Ky PHONE NO : 510 8284757
4245 Technology Drive SE DECISION MADE: 22-JUN-23
Fremont CA 94565 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: F3D Interbody System
Corelink, LLC 510(k) NO: K230329(Traditional)
ATTN: Steven Mounts PHONE NO : 888 3497808
2072 Fenton Logistics Blvd. SE DECISION MADE: 06-JUN-23
St. Louis MO 63026 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EarliPoint
EarliTec Diagnostics, Inc 510(k) NO: K230337(Traditional)
ATTN: Ryan Bormann PHONE NO : 612 9655775
755 Commerce Drive, Suite 700 SE DECISION MADE: 29-JUN-23
Decatur GA 30030 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Voluson SWIFT; Voluson SWIFT+
GE Medical Systems Ultrasound & Pr510(k) NO: K230346(Traditional)
ATTN: Bryan Behn PHONE NO : 262 2475502
9900 Innovation Dr. SE DECISION MADE: 20-JUN-23
Wauwatosa WI 53226 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KOH Ultramicro Injection Cannula (26167NN); Suction a. Irrig. Cannula,L. 36cm (37360CP); Suction a. Irrig. Cannula,L. 36cm (37360SC); Suction and Irrig Cannula,l. 36cm (37560LH); Suction a. Irrig. Cannula,L. 30cm (37260LH); KOH Ultramicro Injection Needle (26167NA); Puncture Needle, LUER-lock (26178R); Suction a. Irrig. Cannula,L. 43cm (37460LH); Suction a. Irrig. Cannula,L. 36cm (37360LH); Puncture Needle, dia. 1.6 mm, 36 cm (26175R); Two-Way Stopcock (26167H); Injection Needle, LUER-lock (26178P); Injection Needle, dia. 1.2 mm, 36 cm (26175P); Ascites Suction Tube 11 mm (26120S); Suction and Irrigation Tube (26167ANS); Ascites Suction Tube (26175V); Suction and Irrigation Tube (26167ANL); Suction Tube w/ Protection Basket, 36 cm (26173BK); Suction and Irrigation Tube, size 3 mm (26167LHL); Suction and Irrigation Tube, size 3 mm (26167LH); Suction and Irrigation Tube, size 3 mm (26167LHS); Suction and Irrigation Tube, length 30cm (26172BN); Handle with Two-Way Stopcock (30805);
KARL STORZ Endoscopy America, Inc 510(k) NO: K230359(Traditional)
ATTN: Michael Block PHONE NO : 49 160 93781814
2151 E. Grand Avenue SE DECISION MADE: 23-JUN-23
El Segundo CA 90245 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EUROPA™ Navigated Instruments
MiRus LLC 510(k) NO: K230369(Traditional)
ATTN: Jordan Bauman PHONE NO : 404 3458235
1755 West Oak Parkway, Suite 100 SE DECISION MADE: 23-JUN-23
Marietta GA 30062 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Coronary Dilatation Balloon Catheter (VesPenetrator®), Coronary Dilatation Balloon Catheter (VesTraveler®), Coronary Dilatation Balloon Catheter (VexPander®)
Dongguan TT Medical, Inc 510(k) NO: K230374(Traditional)
ATTN: Yuying Bi PHONE NO : 86 1555 3341910
Bld #1, Rm 501, 502,1 Taoyuan Rd SSE DECISION MADE: 29-JUN-23
Dongguan CN 523808 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ethos Automated Ultrasound Probe Cleaner Disinfector with AquaCide Cleaner/High-Level Disinfectant and QwikCheck Chemical Indicator
CS Medical LLC 510(k) NO: K230381(Traditional)
ATTN: Kendall Ashe PHONE NO : 919 2559472
2179 East Lyon Station Rd SE DECISION MADE: 07-JUN-23
Creedmoor NC 27522 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SpassageQ
Spass Inc. 510(k) NO: K230386(Traditional)
ATTN: Yonghwan Kim PHONE NO : 82 070 88882227
Unit 905, 396 World Cup buk-ro, MaSE DECISION MADE: 15-JUN-23
Seoul KR 03925 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cut Screw - Percutaneous Compression Screw
GM Dos Reis Industria e Comercio L510(k) NO: K230397(Traditional)
ATTN: Guilherme Esteves Pontes PHONE NO : 55 193 7659900
Avenida Pierre Simon de La Place 6SE DECISION MADE: 12-JUN-23
Campinas BR 13069-320 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: K-SHIELD Zen (Model Numbers: PBMH/ PBMA/ PBM)
SB-Kawasumi Laboratories, Inc. 510(k) NO: K230408(Traditional)
ATTN: Shiro Agehama PHONE NO : 81 445 899750
3-15-4 Tonomachi, Kawasaki-ku, KawSE DECISION MADE: 01-JUN-23
Kanagawa JP 210-8602 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DD medical polymers (PMMA)
Dental Direkt GmbH 510(k) NO: K230410(Special)
ATTN: Patrick Berz PHONE NO : 49 522 58631924__
Industriezentrum 106-108 SE DECISION MADE: 23-JUN-23
Spenge DE 32139 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SOMATOM Edge Plus, SOMATOM Confidence, SOMATOM Definition Edge, SOMATOM Definition AS/AS+, SOMATOM Definition AS Open, SOMATOM Drive, SOMATOM Force, SOMATOM Definition Flash
Siemens Medical Solutions USA Inc.510(k) NO: K230421(Traditional)
ATTN: Clayton Ginn PHONE NO : 865 8982692
810 Innovation Drive SE DECISION MADE: 16-JUN-23
Knoxville TN 37932 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Talee, Talee PostOp
Invent Medical USA, LLC 510(k) NO: K230444(Traditional)
ATTN: Jiri Rosicky PHONE NO : 267 3688165
1800 Mearns Rd, Suite Y SE DECISION MADE: 22-JUN-23
Warminster PA 18974 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TiLink-L SI Joint Fusion System
Surgentec, LLC 510(k) NO: K230446(Traditional)
ATTN: Andrew Shoup PHONE NO : 561 9907882
911 Clint Moore Rd SE DECISION MADE: 07-JUN-23
Boca Raton FL 33487 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SGM Femoral Nail System
Changzhou Geasure Medical Apparatu510(k) NO: K230456(Traditional)
ATTN: Jing Huang PHONE NO : 86 1365 6146897
No. 12, Jinfeng Road, West Taihu SSE DECISION MADE: 30-JUN-23
Changzhou CN 213149 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Compact Wearable Pump
Lansinoh Laboratories 510(k) NO: K230469(Traditional)
ATTN: Lindsay Ewers PHONE NO : 727 5423743
99 Canal Center Plaza, Suite 550 SE DECISION MADE: 30-JUN-23
Alexandria VA 22314 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IPL Hair Removal Device Models: MLY-T069
Miley Technology(Hebei) Co., Ltd. 510(k) NO: K230473(Traditional)
ATTN: Hualing Wang PHONE NO : 86 031 05600133
Building 3, High Tech Industrial ZSE DECISION MADE: 15-JUN-23
Handan CN 057750 510(k) STATEMENT
DEVICE: Avitus® Precision Autograft Delivery System
Avitus Orthopaedics, Inc. 510(k) NO: K230492(Traditional)
ATTN: Maxim Budyansky PHONE NO : 860 3727213
6 Armstrong Rd., Suite 107 SE DECISION MADE: 26-JUN-23
Shelton CT 06484 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Bladder AI (AIBV01)
Exo Inc 510(k) NO: K230497(Traditional)
ATTN: Jacqueline Murray PHONE NO : 1 236 8385056___
4201 Burton Drive SE DECISION MADE: 22-JUN-23
Santa Clara CA 95054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ArtiSential Laparoscopic Instruments-Electrodes
LivsMed Inc. 510(k) NO: K230498(Traditional)
ATTN: Dong Wook Lee PHONE NO : 82 707 7094993
#304, D-dong, 700, Pangyo-ro, BundSE DECISION MADE: 05-JUN-23
Seongnam-si KR 13516 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ear Pressure Relief Device(Model:ER813B)
Ningbo Albert Novosino Co., Ltd. 510(k) NO: K230502(Traditional)
ATTN: Victor Zhou PHONE NO : 86 574 87527882
No. 28 Yunshan Middle Road, SanqisSE DECISION MADE: 09-JUN-23
Yuyao CN 315412 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Orthopantomograph™ OP 3D LX
Palodex Group OY 510(k) NO: K230505(Traditional)
ATTN: Frank Ray PHONE NO : 704 3026568
Nahkelantie 160 SE DECISION MADE: 09-JUN-23
Tuusula FI 04300 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PureLift Pro Edition
Xtreem Pulse 510(k) NO: K230506(Special)
ATTN: Andrew Barile PHONE NO : 917 5975436
353 W. 29th St., Suite 3 SE DECISION MADE: 21-JUN-23
New York NY 10001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Gamma4 System
Stryker GmbH 510(k) NO: K230512(Traditional)
ATTN: Cindy Leon PHONE NO : 201 8315374
325 Corporate Drive SE DECISION MADE: 09-JUN-23
Mahwah NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Blood Tubing Lines for Hemodialysis AL Series (Archloop), Blood Tubing Lines for Hemodialysis C18 Series
Nikkiso Co., Ltd. 510(k) NO: K230514(Traditional)
ATTN: Satoko Hina PHONE NO : 81 3 34433754
20-3, Ebisu 4-Chome SE DECISION MADE: 16-JUN-23
Shibuya-ku JP 150-6022 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HydraDose Vaginal Suppositories
MD Labs LLC 510(k) NO: K230518(Traditional)
ATTN: Harout Achekian PHONE NO : 132 3236 4411
780 Lakefield Road, Suite H SE DECISION MADE: 23-JUN-23
Westlake Village CA 91361-2628 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Single-use Flexible Rhinolaryngoscope; Digital Video Monitor
Hunan Vathin Medical Instrument Co510(k) NO: K230536(Traditional)
ATTN: Du Jing PHONE NO : 86 731 55558558
1/F, Building 12, Innovation and ESE DECISION MADE: 14-JUN-23
Xiangtan CN 411100 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: All-Day Clear Slim ADCS1 Hearing Aid. All-Day Clear ADC1 Hearing Aid
Sonova AG 510(k) NO: K230538(Traditional)
ATTN: Nelson Hu PHONE NO : 1 226 3381048
Laubisruetistrasse 28 SE DECISION MADE: 16-JUN-23
Zurich CH 8712 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OptiVu™ ROSA® MxR
Orthosoft Inc. (d/b/a Zimmer CAS) 510(k) NO: K230567(Traditional)
ATTN: Mona Mansouri PHONE NO : 001 647 6378950
75 Queen Street Suite 3300 SE DECISION MADE: 13-JUN-23
Montreal CA H3C 2N6 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AETOS Shoulder System
Smith & Nephew, Inc. 510(k) NO: K230572(Traditional)
ATTN: Patrick Hughes PHONE NO : 352 3597940
7135 Goodlett Farms Parkway SE DECISION MADE: 07-JUN-23
Cordova TN 38016 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Powder Free Latex Patient Examination Glove, Black Colored, Non-sterile, with Protein Content labeling Claim (Contains 50 ug per dm2 of glove or less of Total Water Extractable Protein)
Kossan International Sdn Bhd 510(k) NO: K230573(Traditional)
ATTN: Cho Sow Fong PHONE NO : 60 332 910516
Wisma Kossan, Lot 782, Jalan SungaSE DECISION MADE: 13-JUN-23
Klang MY 42100 510(k) STATEMENT
DEVICE: Vein360 Reprocessed Visions PV.035 Digital IVUS Catheter
Vein 360 LLC 510(k) NO: K230584(Traditional)
ATTN: Suzanne Meyer PHONE NO : 513 5541300
4460 Lake Forest Dr Suite 230 SE DECISION MADE: 06-JUN-23
Blue Ash OH 452423741 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Renuvion® Micro Handpiece
Apyx Medical Corporation 510(k) NO: K230586(Traditional)
ATTN: Mark D Evans PHONE NO : 856 5245037
(formerly Bovie Medical CorporatioSE DECISION MADE: 09-JUN-23
Clearwater FL 33760-4004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OsteoCentric ACL Fixation System
OsteoCentric Technologies 510(k) NO: K230595(Traditional)
ATTN: Todd Evans PHONE NO : 1 800 9690639
75 West 300 North Suite 150 SE DECISION MADE: 29-JUN-23
Logan UT 84321 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TargetCool™
RecensMedical, Inc. 510(k) NO: K230599(Traditional)
ATTN: Lee Yeonui PHONE NO : 82 31 80433064
#507, #908, SK V1 center, 830 DongSE DECISION MADE: 22-JUN-23
Hwaseong-si KR 18468 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Surgical Face Mask (L 175*95mm)
Henan Chaoya Medical Equipment Co.510(k) NO: K230617(Traditional)
ATTN: Ruihua Miao PHONE NO : 86 180 39303229
No. 19, 13th Street, Economic and SE DECISION MADE: 01-JUN-23
Zhengzhou CN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: APOLLO ADVANTAGE Nitrile Examination Gloves
Dell Corning Corporation 510(k) NO: K230633(Traditional)
ATTN: Sam Chebeir PHONE NO : 800 5276283
575 John Dodd Road SE DECISION MADE: 05-JUN-23
Spartanburg SC 29303 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Pen Needle
Jiangsu Caina Medical Co., Ltd. 510(k) NO: K230635(Traditional)
ATTN: Camel Zhou PHONE NO : 86 510 86205183
No.23, Huanxi Road, Zhutang Town SE DECISION MADE: 02-JUN-23
Jiangyin CN 214415 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD BBL™ Sensi-Disc™ Lefamulin 20µg (LMU-20)
Becton, Dickinson and Company 510(k) NO: K230651(Traditional)
ATTN: Katherine Cicala PHONE NO : 908 5176281
7 Loveton Circle SE DECISION MADE: 07-JUN-23
Sparks MD 21152-0999 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Zionic Aesthetic
TermoSalud 510(k) NO: K230659(Traditional)
ATTN: Cristina Cifuentes Pantoja PHONE NO : 34 985 167547
Calle Ataulfo Friera Tarfe, 8-3321SE DECISION MADE: 08-JUN-23
Gijon ES 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AviClear Laser System
Cutera, Inc. 510(k) NO: K230660(Traditional)
ATTN: Amogh Kothare PHONE NO : 415 6575730
3240 Bayshore Blvd. SE DECISION MADE: 06-JUN-23
Brisbane CA 94005 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HyperVue™ Imaging System
SpectraWAVE Inc 510(k) NO: K230691(Traditional)
ATTN: Farzad Parsaie PHONE NO : 781 3070974
12 Oak Park Drive SE DECISION MADE: 07-JUN-23
Bedford MA 01730 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EMBOLD™ Soft Detachable Coil System
Boston Scientific Corporation 510(k) NO: K230706(Traditional)
ATTN: Laura Judge PHONE NO : 353 86 1777184
300 Boston Scientific Way MarlboroSE DECISION MADE: 27-JUN-23
Boston MA 01752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Auryon Atherectomy System
Eximo Medical Ltd. 510(k) NO: K230709(Special)
ATTN: Yoel Zabar PHONE NO : 97 286 307639
Pekeris St 3 SE DECISION MADE: 09-JUN-23
Rehovot IL 7670203 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Promisemed Safety Huber Needle
Promisemed Hangzhou Meditech Co., 510(k) NO: K230715(Traditional)
ATTN: Zearou Yang PHONE NO : 86 571 88772985
No.1388 Cangxing Street, Cangqian SE DECISION MADE: 08-JUN-23
Hangzhou City CN 311121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UTC 3mL Medication Cartridge
Gilero, LLC 510(k) NO: K230718(Traditional)
ATTN: Jessica Czamanski PHONE NO : 754 4229101
635 Davis Drive Ste 100 SE DECISION MADE: 15-JUN-23
Morrisville NC 27560 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPY Portable Handheld Imaging (SPY-PHI) System
Novadaq Technologies ULC (a part o510(k) NO: K230727(Traditional)
ATTN: Cara Cahill PHONE NO : 240 8825775
8329 Eastlake Drive, Unit 101 SE DECISION MADE: 05-JUN-23
Burnaby CA V5A 4W2 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: JUSHA-C810G/C810G LCD Monitor, JUSHA-C660/JUSHA-C660G/C660/C660G LCD Monitor
Nanjing Jusha Display Technology C510(k) NO: K230728(Traditional)
ATTN: Donny Lee PHONE NO : 86 25 83305050
8A, Block 1. Nanjing InternationalSE DECISION MADE: 09-JUN-23
Nanjing CN 210036 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Zavation ALIF System
Zavation Medical Products, LLC 510(k) NO: K230731(Traditional)
ATTN: Frankie Cummins PHONE NO : 601 9191119
3670 Flowood Dr. SE DECISION MADE: 14-JUN-23
Flowood MS 39232 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Acumed Acutrak 3 Headless Compression Screw System
Acumed LLC 510(k) NO: K230744(Traditional)
ATTN: Phillip Saddik PHONE NO : 917 5865641
5885 NE Cornelius Pass Road SE DECISION MADE: 09-JUN-23
Hillsboro OR 97124 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SafeLan® (2 models/SafeLan 26G, SafeLan 30G), SafeLan®-Pro (1 model/SafeLan®-Pro)
Bosungmeditech Co., Ltd. 510(k) NO: K230759(Traditional)
ATTN: Yang Ho Song PHONE NO : 82 10 87904789
#F, 107 Donghwagongdan-ro, Munmak-SE DECISION MADE: 13-JUN-23
Wonju KR 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRIGEN META-NAIL Nail System
Smith & Nephew Inc. 510(k) NO: K230761(Traditional)
ATTN: Hiral Rathod PHONE NO : 901 2054852
1450 Brooks Rd E SE DECISION MADE: 14-JUN-23
Memphis TN 38116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EDEN Spinal Fixation MIS System
JMT Co., Ltd. 510(k) NO: K230762(Special)
ATTN: Sang-Ok Nam PHONE NO : 82 704 2878353
70-39, Gwonyul-ro 1203beon-gil, BaSE DECISION MADE: 15-JUN-23
Yangju-si KR 11517 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium Diagnostic Ultrasound System
Shenzhen Mindray Bio-Medical Elect510(k) NO: K230768(Traditional)
ATTN: Tang Jing PHONE NO : 86 755 81885695
Keji 12th Road South, Hi-tech InduSE DECISION MADE: 09-JUN-23
Shenzhen CN 518057 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PERLA® TL System; TEKTONA® HV US Bone Cement
Spineart 510(k) NO: K230774(Traditional)
ATTN: Franck Pennesi PHONE NO : 41 22 5701200
3 Chemin de Pré Fleuri 1228 Plan LSE DECISION MADE: 23-JUN-23
Geneva CH 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Momcozy Wearable Electric Breast Pump ( Model: S9 Pro, S12 Pro)
Shenzhen Lutejiacheng Technology C510(k) NO: K230776(Traditional)
ATTN: Athena Pan PHONE NO : 86 0755 84861362
#2-2, Floor 2 Hasee Computer BuildSE DECISION MADE: 09-JUN-23
Shenzhen CN 518129 510(k) STATEMENT
DEVICE: Powder Free Nitrile Examination Gloves (Black), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
Shanxi Hongjin Plastic Technology 510(k) NO: K230779(Traditional)
ATTN: Wu Zhigang PHONE NO : 86 311 66179668
Coal Bed Gas Industrial Zone, Qu'eSE DECISION MADE: 09-JUN-23
Linfen CN 042300 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Belle Sensilube
RB Health (US) LLC 510(k) NO: K230781(Traditional)
ATTN: Kaitlyn Chan PHONE NO :
399 Interpace Parkway SE DECISION MADE: 20-JUN-23
Parsippany NJ 07054-0224 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sparrow Ascent
Spark Biomedical, Inc. 510(k) NO: K230796(Traditional)
ATTN: Brent Croft PHONE NO : 1 844 6547775
18208 Preston Road, Suite D9-531 SE DECISION MADE: 20-JUN-23
Dallas TX 75252 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HardyDisk AST Rezafungin 5µg (RZF5)
Hardy Diagnostics 510(k) NO: K230827(Traditional)
ATTN: Anna Klavins PHONE NO : 800 2662222
1430 West McCoy Lane SE DECISION MADE: 01-JUN-23
Santa Maria CA 93455 510(k) STATEMENT
DEVICE: Aneroid Sphygmomanometer
Wenzhou Kangshun Medical Devices C510(k) NO: K230859(Traditional)
ATTN: Eric Shi PHONE NO : 86 138 57771939
No. 706 Yanyun Road,Lingkun StreetSE DECISION MADE: 28-JUN-23
Wenzhou City CN 325011 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VADER® Pedicle System Navigated Instruments
Icotec ag 510(k) NO: K230861(Traditional)
ATTN: Marina Hess PHONE NO : 41 717 570024
Industriestrasse 12 SE DECISION MADE: 27-JUN-23
9450 Alstatten (SG) CH 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HotDog Warming Mattress + Return Electrode
Augustine Temperature Management, 510(k) NO: K230866(Traditional)
ATTN: Garrett Augustine PHONE NO : 952 4653529
7656 W. 78th St. SE DECISION MADE: 29-JUN-23
Minneapolis MN 55439 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Bone Bolt System
University of Utah, Department of 510(k) NO: K230867(Traditional)
ATTN: Wade Fallin PHONE NO : 801 5872938
590 Wakara Way SE DECISION MADE: 26-JUN-23
Salt Lake City UT 84108 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RI.KNEE Adjustable Tibia Cut Guide
Enztec Limited 510(k) NO: K230876(Traditional)
ATTN: Breanna Crowther PHONE NO : 64 22 1318279
3/17 Print Place SE DECISION MADE: 27-JUN-23
Middleton NZ 8024 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Connected OR Hub with Device and Voice Control; SDC4K Information Management System with Device and Voice Control
Stryker Endoscopy 510(k) NO: K230886(Special)
ATTN: Lauren Bentley PHONE NO : 484 9850736
5900 Optical Ct SE DECISION MADE: 21-JUN-23
San Jose CA 95138 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Titanium Turbine
Nakanishi Inc. 510(k) NO: K230888(Traditional)
ATTN: Masaaki Kikuchi PHONE NO : 81 289 647277
700 Shimohinata SE DECISION MADE: 02-JUN-23
Kanuma JP 322-8666 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Fixone Biocomposite Anchor
Aju Pharm Co., Ltd. 510(k) NO: K230892(Special)
ATTN: Kwon Mingyeong PHONE NO : 82 2 26300629
A-207, 697, Pangyo-ro SE DECISION MADE: 09-JUN-23
Seongnam KR 13511 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NuVasive Modulus ALIF System
NuVasive, Incorporated 510(k) NO: K230894(Traditional)
ATTN: Alexander Stevens PHONE NO : 347 6203110
7475 Lusk Blvd SE DECISION MADE: 16-JUN-23
San Diego CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Arthrex Virtual Implant Positioning (VIP) System
Arthrex Inc. 510(k) NO: K230904(Traditional)
ATTN: Troy Brooks PHONE NO : 1 239 6435553
1370 Creekside Boulevard SE DECISION MADE: 22-JUN-23
Naples FL 34108-1945 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OrthoPulse 2.0E (OPi2E-100)
Biolux Technology GmbH 510(k) NO: K230905(Special)
ATTN: Daniela Penn PHONE NO : 49 632 19164033
Neubaugasse 31 SE DECISION MADE: 09-JUN-23
Absdorf AT 3462 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NewVision SC (tisilfocon A) Scleral Lens; NewVision SC Daily Wear Ortho-K (tisilfocon A) Corneo-Scleral Lens
Acculens, Inc. 510(k) NO: K230910(Traditional)
ATTN: Troy Miller PHONE NO : 303 2326244
5353 West Colfax Avenue SE DECISION MADE: 16-JUN-23
Lakewood CO 80214 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARIS¿ COBLATION¿ Turbinate Reduction Wand (72290113); WEREWOLF COBLATION System (72290144); WEREWOLF+ COBLATION System (72290146)
Arthrocare Corporation 510(k) NO: K230914(Traditional)
ATTN: Pragnya Bakka PHONE NO : 973 9957606
7000 West William Cannon Drive SE DECISION MADE: 26-JUN-23
Austin TX 78735 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FebriDx Bacterial / Non-bacterial Point of Care Assay
Lumos Diagnostics, Inc. 510(k) NO: K230917(Traditional)
ATTN: Sue Hibbeln PHONE NO : 503 7301901
2724 Loker Avenue SE DECISION MADE: 30-JUN-23
Carlsbad CA 92010 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: enspire 3000 Cleaning and Liquid Chemical Sterile Processing System
STERIS Corporation 510(k) NO: K230930(Traditional)
ATTN: Anthony Piotrkowski PHONE NO : 440 3927437
5960 Heisley Road SE DECISION MADE: 30-JUN-23
Mentor OH 44060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REMI Remote EEG Monitoring System
Epitel, Inc. 510(k) NO: K230933(Traditional)
ATTN: Randy Parry PHONE NO : 801___ 8367318
465 South 400 East SE DECISION MADE: 30-JUN-23
Salt Lake City UT 84111 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC, or Breakpoint Susceptibility System with Imipenem-relebactam in the dilution, range of 0.03/4-128-4ug/ml (Haemophilus influenzae)
Thermo Fisher Scientific 510(k) NO: K230935(Traditional)
ATTN: Cynthia Knapp PHONE NO : 800 8718909
One Thermo Fisher Way SE DECISION MADE: 30-JUN-23
Oakwood Village OH 44146 510(k) STATEMENT
DEVICE: Anatomic PEEK™ Cervical Fusion System with Nanotechnology
Nanovis LLC 510(k) NO: K230936(Traditional)
ATTN: Brian More PHONE NO : 877 9076266
5865 East State Rd. 14 SE DECISION MADE: 02-JUN-23
Columbia City IN 46725 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Alinity i Total ß-hCG Reagent Kit, GLP systems Track
Abbott Laboratories 510(k) NO: K230937(Traditional)
ATTN: Melissa Vaughan PHONE NO : 972 5186895
1915 Hurd Drive SE DECISION MADE: 05-JUN-23
Irving TX 75038 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MeMed BV
MeMed Diagnostics Ltd. 510(k) NO: K230944(Traditional)
ATTN: Efrat Hartog-David PHONE NO : 97 248 500302
Nahum Het 7 SE DECISION MADE: 30-JUN-23
Tirat Carmel IL 3508506 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Triathlon® Total Knee System - Triathlon® Pro Posterior Stabilized (PS) Femoral Component
Howmedica Osteonics Corp. dba Stry510(k) NO: K230952(Traditional)
ATTN: Jane Guo PHONE NO : 269 8002081
325 Corporate Drive SE DECISION MADE: 02-JUN-23
Mahwah NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Acuity 100™ (hexafocon A) with Tangible™ Hydra-PEG®, TYRO™-97 (hofocon A) with Tangible™ Hydra-PEG® Rigid Gas Permeable Contact Lens
Acuity Polymers, Inc. 510(k) NO: K230965(Traditional)
ATTN: Chavez Jose PHONE NO : 949 8700278
1667 Lake Ave Building 59, Suite 3SE DECISION MADE: 16-JUN-23
Rochester NY 14615 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: APTUS® 3.5 TriLock Straight Plates
Medartis AG 510(k) NO: K230971(Traditional)
ATTN: Claudia De Santis PHONE NO : 41 61 6333434
Hochbergerstrasse 60E SE DECISION MADE: 02-JUN-23
Basel CH CH-4057 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Candela Vbeam Family of Pulsed Dye Lasers (Vbeam Prima, Vbeam Perfecta)
Candela Corporation 510(k) NO: K230990(Traditional)
ATTN: Danielle Gibboney PHONE NO : 617 9043820
251 Locke Drive SE DECISION MADE: 01-JUN-23
Marlborough MA 01752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E
Given Imaging Ltd. (Medtronic) 510(k) NO: K230991(Special)
ATTN: Breanna Hessler PHONE NO : 763 3987010
2 Hacarmel St. New Industrial ParkSE DECISION MADE: 30-JUN-23
Yoqneam IL 20692 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DJF Intravascular Administration Set
Yangzhou Wei De Li Trade Co. Ltd 510(k) NO: K230992(Traditional)
ATTN: Joyce Wu PHONE NO : 86 514 87897887
Room 2412, Bldg.5, Cai Fu Plaza, 2SE DECISION MADE: 09-JUN-23
Yangzhou CN 225000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CODA™ Anterior Cervical Plate System
Pioneer Surgical Technology, Inc D510(k) NO: K230993(Special)
ATTN: Alicia Kaufman PHONE NO : 763 7726137
375 River Park Circle SE DECISION MADE: 20-JUN-23
Marquette MI 49855 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Javelot PK-S suture anchor, Javelot PK-S suture anchor (Knotless), Javelot PK-P suture anchor, Javelot PK-P suture anchor (Knotless), Javelot PK-L suture anchor (Knotless)
Suzhou Endophix Co., Ltd. 510(k) NO: K231002(Traditional)
ATTN: Jaun Wu PHONE NO : 86 175 21559984
NO. 151, Fengli Road SE DECISION MADE: 07-JUN-23
Suzhou CN 215000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Pounce™ Thrombectomy System
Surmodics Inc. 510(k) NO: K231022(Traditional)
ATTN: Holly Ramirez PHONE NO : 1 952 5007545
7905 Golden Triangle Drive Suite 1SE DECISION MADE: 12-JUN-23
Eden Prairie MN 55344 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ERBEJET® 2 System
Erbe Elektromedizin GmbH 510(k) NO: K231023(Traditional)
ATTN: Matthias Kollek PHONE NO : 49 171 6853719
Waldhoernlestrasse 17 SE DECISION MADE: 15-JUN-23
Tuebingen DE 72072 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACL TOP Family 70 Series
Instrumentation Laboratory Company510(k) NO: K231031(Traditional)
ATTN: Carol Marble PHONE NO : 781 8614467
180 Hartwell Road SE DECISION MADE: 21-JUN-23
Bedford MA 01730 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MyKnee UNI-ST
Medacta International S.A. 510(k) NO: K231037(Traditional)
ATTN: Stefano Baj PHONE NO : 41 91 6966060
Strada Regina SE DECISION MADE: 09-JUN-23
Castel San Pietro CH 6874 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Laparoscopic Trocar
Changzhou Ankang Medical Instrumen510(k) NO: K231042(Traditional)
ATTN: Tingting Cao PHONE NO : 86 519 68021374
A4 Standard Workshop, Hutang ScienSE DECISION MADE: 08-JUN-23
Changzhou CN 213162 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Healgen URS Test Strips
Healgen Scientific LLC 510(k) NO: K231045(Traditional)
ATTN: Jianqiu Fang PHONE NO : 713 7338088
5213 Maple St SE DECISION MADE: 16-JUN-23
Bellaire TX 77401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Fluorescence Accessories (YELLOW 560 and INFRARED 800 with FLOW 800 Option)
Carl Zeiss Meditec Inc 510(k) NO: K231075(Traditional)
ATTN: Chaitali Gawde PHONE NO : 244 3003992
5300 Central Parkway SE DECISION MADE: 20-JUN-23
Dublin CA 94568 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Zevo Anterior Cervical Plate System
Medtronic Sofamor Danek USA, Inc. 510(k) NO: K231090(Traditional)
ATTN: Scott P. Baker PHONE NO : 1 800 8763133
1800 Pyramid Place SE DECISION MADE: 15-JUN-23
Memphis TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Flume Catheter
Flume Catheter Company, Ltd. 510(k) NO: K231101(Special)
ATTN: Roger Holmes PHONE NO : 440 207 8089125
The Granary, Milhouse SE DECISION MADE: 29-JUN-23
Farnham GB GU10 3EE 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Xerxes Hip Stem
Xerxes Arthopedix LLC 510(k) NO: K231109(Traditional)
ATTN: H Kurtis Biggs PHONE NO : 239 3130543
181 Eugenia Dr. SE DECISION MADE: 15-JUN-23
Naples FL 34108 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Manual Wheelchair (A006)
Ningbo Shenyu Medical Equipment Co510(k) NO: K231110(Traditional)
ATTN: Ding Jianjun PHONE NO : 0086 574625 17777
No.1318 West of Tanjialing Road, SE DECISION MADE: 16-JUN-23
Yuyao CN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: neXus Ultrasonic Surgical Aspirator System
Misonix, LLC, a Bioventus Company 510(k) NO: K231117(Special)
ATTN: John Salerno PHONE NO : 1 631 6949555
1938 New Highway SE DECISION MADE: 23-JUN-23
Farmingdale NY 11735 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Diode Laser Body Sculpture Systems
Shanghai Bele Medical Technology C510(k) NO: K231131(Traditional)
ATTN: Jeremy Li PHONE NO : 86 152 21991075
Room 402, 4F, Building 1, No.3255 SE DECISION MADE: 22-JUN-23
Shanghai CN 201600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Fitness Belt (Model: KLT-07)
Shenzhen KeLuTongDa Industrial Co.510(k) NO: K231136(Traditional)
ATTN: Zhongliang Luo PHONE NO : 86 755 84895166
217,44-46 Xintun South Road,XinliaSE DECISION MADE: 16-JUN-23
Shenzhen CN 518172 510(k) STATEMENT
DEVICE: Axis Anterior Cervical Plate System
Southern Medical (Pty) Ltd 510(k) NO: K231145(Traditional)
ATTN: Dalene Styger PHONE NO : 27 126 676243
55 Regency Drive Route 21 CorporatSE DECISION MADE: 13-JUN-23
Irene ZA 0178 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ScleroSafe™ 150 mm, ScleroSafe™ 350 mm
VVT Medical Ltd. 510(k) NO: K231148(Traditional)
ATTN: Liron Tayeb PHONE NO : 972 9 7660480
6 Hasadna St. SE DECISION MADE: 20-JUN-23
Kfar Saba IL 4442405 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Neuhat Hair Growth System; ibeauty.com Laser Cap
Nature Incredible Inc 510(k) NO: K231153(Traditional)
ATTN: John Lee PHONE NO : 508 8694606
3422 Old Capitol Trail #569 SE DECISION MADE: 23-JUN-23
Wilmington DE 19808 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: C350/C350G LCD Monitor; M550/M550G LCD Monitor
Nanjing Jusha Display Technology C510(k) NO: K231170(Traditional)
ATTN: Donny Lee PHONE NO : 86 258 3305050
8A, Block 1. Nanjing InternationalSE DECISION MADE: 07-JUN-23
Nanjing CN 210036 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MapRT
Vision RT Ltd 510(k) NO: K231185(Traditional)
ATTN: Jade Dunphy PHONE NO : 44 208 3464300
Dove House, Arcadia Avenue SE DECISION MADE: 23-JUN-23
London GB N3 2JU 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Solar Lumbar Interbody Fusion System
DeGen Medical 510(k) NO: K231199(Traditional)
ATTN: Craig Black PHONE NO : 843___ 9924551
1321-C North Cashua Drive SE DECISION MADE: 16-JUN-23
Florence SC 29501 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QuickRayPRO
Denterprise International Inc. 510(k) NO: K231202(Traditional)
ATTN: Claude Berthoin PHONE NO : 386 6720450
156 E Granada Blvd SE DECISION MADE: 22-JUN-23
Ormond Beach FL 32176 510(k) STATEMENT
DEVICE: da Vinci E-200 Electrosurgical Generator
Intuitive Surgical 510(k) NO: K231212(Traditional)
ATTN: Shamsa Karimi PHONE NO : 408 8066720
1266 Kifer Road SE DECISION MADE: 21-JUN-23
Sunnyvale CA 94086 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IPL Hair Removal Device Model: Skin Expert Pro IPL 008, Skin Expert Pro IPL 008S
ZhongShan Qizhe Technology Co., Lt510(k) NO: K231215(Traditional)
ATTN: Gan Guiping PHONE NO : 86 13902 957808
23 Tongji West Road, Nantou Town, SE DECISION MADE: 26-JUN-23
ZhongShan CN 528427 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NobelZygoma PureSet™ Tray
Nobel Biocare Services AG 510(k) NO: K231219(Traditional)
ATTN: Bernice Jim PHONE NO : 41 79 8550073
Balz Zimmermann-Str. 7 SE DECISION MADE: 27-JUN-23
Kloten CH 8302 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Curiteva Laminoplasty System
Curiteva, Inc. 510(k) NO: K231232(Traditional)
ATTN: Eric Linder PHONE NO : 256 2131057
25127 Will McComb Drive SE DECISION MADE: 28-JUN-23
Tanner AL 35671 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ventana™ L Spinal System
Spinal Elements, Inc. 510(k) NO: K231252(Traditional)
ATTN: Julie Lamothe PHONE NO : 760 6071816
3115 Melrose Dr., Suite 200 SE DECISION MADE: 30-JUN-23
Carlsbad CA 92010 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Easy On Universal Glaze & Stain
Doctus Global 510(k) NO: K231264(Traditional)
ATTN: Beom-jin Choi PHONE NO : 82 10 89895741
RN.313, 51, Samwon-ro, Deogyang-guSE DECISION MADE: 30-JUN-23
Goyang-si KR 10550 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ClearTip
Finemedix Co., Ltd. 510(k) NO: K231267(Traditional)
ATTN: Seok-Jun Ma PHONE NO :
140-9, Yuram-ro, Dong-gu SE DECISION MADE: 30-JUN-23
Daegu KR 41059 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Drakon™ and Sequre® Microcatheters
Accurate Medical Therapeutics 510(k) NO: K231293(Special)
ATTN: Osnat Harbater PHONE NO : 97 254 4557493
19 Eli Hurvitz Street SE DECISION MADE: 01-JUN-23
Rehovot IL 7608802 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: cobas SARS-CoV-2 Qualitative for use on the cobas 5800/6800/8800 Systems
Roche Molecular Systems, Inc. 510(k) NO: K231306(Special)
ATTN: Caroline Sobek PHONE NO : 925 4169705
4300 Hacienda Drive SE DECISION MADE: 01-JUN-23
Pleasanton CA 94028 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SCAR 3
El.en Electroinc Engineering Spa 510(k) NO: K231309(Special)
ATTN: Paolo Peruzzi PHONE NO : 39 055 8826807
Via Baldanzese 17 SE DECISION MADE: 02-JUN-23
Calenzano IT 50041 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CPS Direct™ Universal slittable outer guide catheter (DS2C029)
Abbott Medical 510(k) NO: K231311(Special)
ATTN: Mary Adams PHONE NO : 909 9915235
15900 Valley View Court SE DECISION MADE: 02-JUN-23
Sylmar CA 91342 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Fine Osteotomy™
BodyCad Laboratories, Inc. 510(k) NO: K231314(Special)
ATTN: Nadine Adia PHONE NO : 418 5271388
2035 rue du Haut-Bord SE DECISION MADE: 02-JUN-23
Quebec City CA G1N 4R7 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Zhenjiang Assure Mechanical Wheelchair,model:K1
Zhenjiang Assure Medical Equipment510(k) NO: K231320(Special)
ATTN: Eric Shi PHONE NO : 86 1862 1771627
No.297, Chuqiao road, SE DECISION MADE: 05-JUN-23
Zhenjiang city CN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Fix2Lock(PEEK Self Punching)
Osteonic Co., Ltd. 510(k) NO: K231322(Special)
ATTN: Da Kyung Ham PHONE NO : 82 2 69028456
1206Ho, 38, Digital-ro, 29-gil, GuSE DECISION MADE: 07-JUN-23
Seoul KR 08381 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FiberTak® Suture Anchor
Arthrex Inc. 510(k) NO: K231330(Special)
ATTN: Erikka Edwardsen PHONE NO : 1 239 6435553 70422
1370 Creekside Boulevard SE DECISION MADE: 01-JUN-23
Naples FL 34108-1945 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BruxZir™ TintEFX Coloring Liquid
Prismatik Dentalcraft, Inc. 510(k) NO: K231347(Special)
ATTN: Nina Chiang PHONE NO : 949 2232258
2144 Michelson Drive SE DECISION MADE: 09-JUN-23
Irvine CA 92612 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Elecsys ß-Amyloid (1-42) CSF II, Elecsys Total-Tau CSF
Roche Diagnostics 510(k) NO: K231348(Traditional)
ATTN: Greg Mondics PHONE NO : 317 6008647
9115 Hague Rd. SE DECISION MADE: 05-JUN-23
Indianapolis IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs and Fentanyl)
Nephron Nitrile, LLC. 510(k) NO: K231349(Special)
ATTN: Lou Kennedy PHONE NO : 844 9373888
4777 12th Street Extension SE DECISION MADE: 06-JUN-23
West Columbia SC 29172 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OCD MT Cap (85-00397-000)
Neuronetics 510(k) NO: K231350(Special)
ATTN: Amanda Pentecost PHONE NO : 610 6404202
3222 Phoenixville Pike SE DECISION MADE: 08-JUN-23
Malvern PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RODIN™ Expandable Lumbar Cage System
CTL Medical Corporation 510(k) NO: K231359(Special)
ATTN: Sean Suh PHONE NO : 214 5455820
4550 Excel Pkwy Ste 300 SE DECISION MADE: 09-JUN-23
Addison TX 75001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ambra PACS
DICOM Grid dba Ambra Health 510(k) NO: K231360(Third Party - Special)
ATTN: Ashley Brown PHONE NO : 1 828 2924758___
450 Park Ave S 10th Floor SE DECISION MADE: 07-JUN-23
New York NY 10016 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: Bemer Therapy System Evo
Bemer INT AG 510(k) NO: K231368(Third Party - Traditional)
ATTN: Sandra Schwarzenberger PHONE NO : 423 3993999
Austrasse 15 SE DECISION MADE: 09-JUN-23
Triesen LI 9495 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: ClearumTM HS
Bellco Srl 510(k) NO: K231406(Special)
ATTN: Rekha Roveri PHONE NO : 39 0535 29486
Via Camurana 1 SE DECISION MADE: 14-JUN-23
Mirandola IT 41037 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Intimate Rose Vaginal Dilators
Plus EV Holdings dba Intimate Rose510(k) NO: K231430(Third Party - Traditional)
ATTN: Aaron Wilt PHONE NO : 816 8056722
1419 Murray Street SE DECISION MADE: 07-JUN-23
North Kansas City MO 64116 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: HepaFatSmart (V2.0.0)
Resonance Health Analysis Services510(k) NO: K231459(Special)
ATTN: Mitchell Wells PHONE NO : 61 892 865300
141 Burswood Road SE DECISION MADE: 20-JUN-23
Burswood AU 6100 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Smart Correction System (HA Half Pins)
WishBone Medical, Inc. 510(k) NO: K231461(Special)
ATTN: Kellie Myers PHONE NO : 574 3064006
100 Capital Drive SE DECISION MADE: 16-JUN-23
Warsaw IN 46582 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RxSight Insertion Device
RxSight, Inc. 510(k) NO: K231466(Special)
ATTN: Maureen O'Connell PHONE NO : 978 2071245
100 Columbia SE DECISION MADE: 12-JUN-23
Aliso Viejo CA 92656 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 1417WCE, 1417WCE-HR, 1417WCE-HS, 1417WCE-GF
Rayence Co., Ltd 510(k) NO: K231467(Special)
ATTN: Kevin Kim PHONE NO : 82 31 80156459
14, Samsung 1-ro, 1-gil SE DECISION MADE: 21-JUN-23
Hwaseong-si KR 18449 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PAXgene® Blood DNA Tube
PreAnalytiX GmbH 510(k) NO: K231469(Special)
ATTN: Alexandra Kirby PHONE NO : 862 7742318
Garstligweg 8 SE DECISION MADE: 21-JUN-23
Hombrechtikon CH 8634 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: iLet® ACE Pump
Beta Bionics, Inc. 510(k) NO: K231485(Special)
ATTN: Liz Cooper PHONE NO : 732 2755848
300 Baker Ave Ste 301 SE DECISION MADE: 21-JUN-23
Concord MA 01742-2131 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sturdy Autoclave Super Microm
Sturdy Industrial Co., Ltd 510(k) NO: K231489(Special)
ATTN: Wolfgang Huang PHONE NO : 886 229 815245601
No. 168 Sec. 1, Zhongxing Road, WuSE DECISION MADE: 21-JUN-23
New Taipei City TW 24872 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GORE® ACUSEAL Vascular Graft
W. L. Gore & Associates, Inc. 510(k) NO: K231505(Special)
ATTN: Sarah Pastrnak PHONE NO : 1 928 8644146
1505 N. Fourth Street SE DECISION MADE: 23-JUN-23
Flagstaff AZ 86004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ActiGraph LEAP activity monitor (ActiGraph LEAP)
ActiGraph, LLC 510(k) NO: K231532(Special)
ATTN: Brian Bell PHONE NO : 850 7237184
70 North Baylen Street, Suite 400 SE DECISION MADE: 23-JUN-23
Pensacola FL 32504 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Habib EndoHPB
Boston Scientific Corporation 510(k) NO: K231533(Special)
ATTN: Carter Navarro PHONE NO : 508 3820356
100 Boston Scientific Way SE DECISION MADE: 21-JUN-23
Marlborough MA 01752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System
Boston Scientific Corporation 510(k) NO: K231549(Special)
ATTN: Jotham Moon PHONE NO : 508 6834208
100 Boston Scientific Way SE DECISION MADE: 29-JUN-23
Marlborough MA 01752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OverStitch NXT Endoscopic Suturing System
Apollo Endosurgery Inc. 510(k) NO: K231553(Special)
ATTN: James Shene PHONE NO : 512 8523793
1120 South Capital of Texas Hwy., SE DECISION MADE: 29-JUN-23
Austin TX 78746 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vantage PSI System
3D Systems, Inc. 510(k) NO: K231585(Special)
ATTN: Ashley Dawson PHONE NO : 1 803 3263908
5381 South Alkire Circle SE DECISION MADE: 30-JUN-23
Littleton CO 80127 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ViewFlex™ Eco Reprocessed ICE Catheter
Abbott Medical 510(k) NO: K231588(Special)
ATTN: Quynh Phuong Le PHONE NO : 949 4699779
14901 Deveau Place SE DECISION MADE: 30-JUN-23
Minnetonka MN 55345 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IOB Temperature Management System
IOB Medical Inc 510(k) NO: K231596(Third Party - Traditional)
ATTN: Jonathan Kovach PHONE NO : 513 3265295
504E Diamond Ave., Suite I SE DECISION MADE: 30-JUN-23
Gaithersburg MD 20877 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: A-Line Advanced
Biocetec Co., Ltd 510(k) NO: K231635(Third Party - Traditional)
ATTN: Hee Sue Jin PHONE NO : 82 2 7042876
RM 1001,1002, New T Castle, 108 GaSE DECISION MADE: 06-JUN-23
Seoul KR 08506 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation System.
L&K BIOMED Co., Ltd. 510(k) NO: K231636(Special)
ATTN: Katherine Kim PHONE NO : 82____ 10 54770325
#101, 201, 202 16-25 DongbaekjungaSE DECISION MADE: 27-JUN-23
Yongin-si KR 17015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: XENOVIEW 3.0T Chest Coil
Polarean, Inc. 510(k) NO: K231647(Special)
ATTN: Neil Wadehra PHONE NO : 919 2067900
PO Box 14805 SE DECISION MADE: 29-JUN-23
Research Triangle Park NC 27709-4510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: iFuse TORQ® Implant System
Si-Bone, Inc. 510(k) NO: K231689(Special)
ATTN: Meirav Harsat PHONE NO : 650 8624942
47 El Camino Real, Suite 101 SE DECISION MADE: 30-JUN-23
Santa Clara CA 95050 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Phantom XL Insulated Dilators
TeDan Surgical Innovations Inc. 510(k) NO: K231691(Special)
ATTN: Lynne Davies PHONE NO : 713 5542130
12320 Cardinal Meadow Dr. Suite 15SE DECISION MADE: 29-JUN-23
Sugar Land TX 77478 510(k) SUMMARY AVAILABLE FROM FDA
TOTAL 510(k)s THIS PERIOD 300
TOTAL WITH SUMMARIES 288
TOTAL WITH STATEMENTS 12
