510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD September 2022
DEVICE: AugMENTA Penile Implant
Augmenta LLC 510(k) NO: K200073(Traditional)
ATTN: Robert J Cornell PHONE NO : 1 713 2054674
1315 St. Joesph Parkway, Suite 170SE DECISION MADE: 30-SEP-22
Houston TX 77002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FINDER G6PD
Baebies, Inc. 510(k) NO: K201049(Traditional)
ATTN: Ailen Gillette PHONE NO : 919 6739706
615 Davis Drive Suite 800 SE DECISION MADE: 14-SEP-22
Morrisville NC 27560 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Soteria Bed Barrier
Trinity Guardion 510(k) NO: K201876(Traditional)
ATTN: Bruce Rippe PHONE NO : 812 9322602
4 S Park Ave Ste 204 SE DECISION MADE: 01-SEP-22
Batesville IN 47006 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: A.B. Dental Devices Dental Implants System
A.B. Dental Device Ltd. 510(k) NO: K202144(Traditional)
ATTN: Gabi Krauss PHONE NO : 972 8 8531388
19 Hayalomim Street SE DECISION MADE: 23-SEP-22
Ashdod IL 7761117 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nexpowder
Nextbiomedical Co., Ltd. 510(k) NO: K202929(Traditional)
ATTN: Jin Young Lee PHONE NO : 82 32 4544800
6 Venture-ro 100 beon-gil, Yeonsu-SE DECISION MADE: 16-SEP-22
Incheon KR 22013 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Thermo Scientific Oxoid Omadacycline Disc (30 ug) OMC30
Oxoid Limited (part of Thermo Fish510(k) NO: K203336(Traditional)
ATTN: Philip Brame PHONE NO : 44 0 1256694279
Wade Road SE DECISION MADE: 15-SEP-22
Basingstoke GB RG24 8PW 510(k) STATEMENT
DEVICE: Camber Sacroiliac (SI) Fixation System
Camber Spine Technologies, LLC 510(k) NO: K203503(Traditional)
ATTN: Daniel A. Pontecorvo PHONE NO : 484 4204671
501 Allendale Road SE DECISION MADE: 02-SEP-22
King of Prussia PA 19604 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EyeCTester
Neuro-Eye Diagnostic Systems LLC 510(k) NO: K203594(Traditional)
ATTN: Jade S. Schiffman PHONE NO : 281 7010577
2020 Quenby St. SE DECISION MADE: 07-SEP-22
Houston TX 77005 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EQ-M
Meta Systems Co., Ltd 510(k) NO: K210475(Traditional)
ATTN: Yang Ho Dong PHONE NO : 82 31 7317377
#1214-18, Sicox tower 12F, 484, DuSE DECISION MADE: 21-SEP-22
Seongnam-si KR 13229 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 8mm Monopolar Curved Scissors
Iconocare Health 510(k) NO: K210478(Traditional)
ATTN: Rick Ferreira PHONE NO : 480 4678517
7825 East Redfield Rd. Suite 103 SE DECISION MADE: 30-SEP-22
Scottsdale AZ 85260 510(k) STATEMENT
DEVICE: Ultrasonic Surgical System
Miconvey Technologies Co., Ltd. 510(k) NO: K210567(Traditional)
ATTN: Kang Li PHONE NO : 86 23 63171596
No.16 Fangzheng Avenue, Beibei DisSE DECISION MADE: 30-SEP-22
Chongqing CN 400714 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MagiCath II
Woo Young Medical Co., Ltd. 510(k) NO: K210929(Traditional)
ATTN: Jenny Cho PHONE NO : 82 43 5360291
98, Sangsin2-gil, Jincheon-eup SE DECISION MADE: 13-SEP-22
Jincheon-gun KR 27846 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MammaPrint FFPE NGS Kit
Agendia Inc. 510(k) NO: K210973(Traditional)
ATTN: Marcelo Trevino PHONE NO : 949 5406300
22 Morgan SE DECISION MADE: 08-SEP-22
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Altus Spine Pedicle Screw System
Altus Partners, LLC 510(k) NO: K211027(Traditional)
ATTN: Mark Melton PHONE NO : 610 3554156
1340 Enterprise Drive SE DECISION MADE: 16-SEP-22
West Chester PA 19380 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DURAMESH Mesh Suture
MSi 510(k) NO: K211178(Traditional)
ATTN: Greg Dumanian PHONE NO : 312 9726845
One Magnificent Mile 980 N. Lake SSE DECISION MADE: 02-SEP-22
Chicago IL 60611 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SafePort(TM) Manifold (or Stopcock)
Elcam Medical ACAL 510(k) NO: K211204(Traditional)
ATTN: Avital Levertov PHONE NO : 972 52 8313380
Kibbutz Baram SE DECISION MADE: 15-SEP-22
Kibbutz Baram IL 1386000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Dual Switch
Laser Engineering, Inc. 510(k) NO: K211605(Special)
ATTN: Laurie Dobbs PHONE NO : 615 7395418
475 Metroplex Drive Suite 401 SE DECISION MADE: 22-SEP-22
Nashville TN 37211 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QIR Suite
CASIS Cardiac Simulation & Imaging510(k) NO: K211611(Traditional)
ATTN: Jean-Joseph Christophe PHONE NO : 33 621 220702
7 impasse des Boussenots SE DECISION MADE: 30-SEP-22
Quetigny FR 21800 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay
Diazyme Laboratories Inc. 510(k) NO: K211648(Traditional)
ATTN: Abhijit Datta PHONE NO : 858 4554762
12889 Gregg Court SE DECISION MADE: 08-SEP-22
Poway CA 92064 510(k) STATEMENT
DEVICE: TULSA-PRO System
Profound Medical Inc. 510(k) NO: K211858(Traditional)
ATTN: Goldy Singh PHONE NO : 1 647 4761350 403
2400 Skymark Avenue Unit #6 SE DECISION MADE: 06-SEP-22
Mississauga CA L4W 5K5 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: InnovaMatrix PD
Triad Life Sciences, Inc. 510(k) NO: K211902(Traditional)
ATTN: Bill Willis PHONE NO : 901 3336000
1770 Moriah Woods Blvd, Suite 18 SE DECISION MADE: 28-SEP-22
Memphis TN 38117 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Neteera 130H/131H Vital Sign Monitoring Sensor
Neteera Technologies Ltd. 510(k) NO: K212143(Traditional)
ATTN: Yael Himmel PHONE NO : 972 2 5808733
Hebrew University Givat Ram CampusSE DECISION MADE: 28-SEP-22
Jerusalem IL 9518702 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Simplexa COVID-19 Direct, Simplexa COVID-19 Positive Control Gen II Pack
DiaSorin Molecular LLC 510(k) NO: K212147(Traditional)
ATTN: Tara Viviani PHONE NO : 562 2406271
11331 Valley View Street SE DECISION MADE: 13-SEP-22
Cypress CA 90630 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FibroLux
Multi Radiance Medical 510(k) NO: K212189(Traditional)
ATTN: Andrey Godes PHONE NO : 440 5420761
6521 Davis Industrial Parkway SE DECISION MADE: 02-SEP-22
Solon OH 44139 510(k) STATEMENT
DEVICE: WasherCap Fixation System
Abanza Tecnomed SL. 510(k) NO: K212197(Traditional)
ATTN: Aitor Olaso PHONE NO : 34 948 044643
Calle Nueva 8-11 SE DECISION MADE: 22-SEP-22
Mutilva ES 31192 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Tempo Smart Button
Eli Lilly and Company 510(k) NO: K212217(Traditional)
ATTN: Kevin S. Bardonner PHONE NO : 317 2095585
Lilly Corporate Center SE DECISION MADE: 16-SEP-22
Indianapolis IL 46285 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Soniquence Reusable 3 Button Fingerswitch Wand
Soniquence, LLC 510(k) NO: K212222(Special)
ATTN: Suzanne Lucas PHONE NO : 516 6341370
2477 Grand Avenue SE DECISION MADE: 02-SEP-22
Baldwin NY 11510 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DoubleChek DC-1001
Nasogastric Feeding Solutions, Ltd510(k) NO: K212316(Traditional)
ATTN: Mark Townend PHONE NO : 44 151 7053466
131 Mount Pleasant SE DECISION MADE: 30-SEP-22
Liverpool GB L3 5TF 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PWD Negative Pressure Wound Therapy System
Applied Tissue Technologies LLC 510(k) NO: K212359(Traditional)
ATTN: Michael Broomhead PHONE NO : 781 3663848
99 Derby St. SE DECISION MADE: 21-SEP-22
Hingham MA 02043 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MTX-C1
ILOODA Co., Ltd 510(k) NO: K212561(Traditional)
ATTN: Yun-Jung Ha PHONE NO : 82 31 2101622
120, Jangan-ro 458 Beon-gil, JangaSE DECISION MADE: 27-SEP-22
Suwon-si KR 16200 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EpiFaith CV
Flat Medical Co., Ltd. 510(k) NO: K212615(Traditional)
ATTN: Tseng Shao Wei PHONE NO : 886 2 25672959 13
9F.-1 No. 27, Sec. 1, Chang'an E. SE DECISION MADE: 21-SEP-22
Taipei City TW 10441 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: iRelieve Microcurrent Pain Relief System
Fast Track Technologies, Inc. 510(k) NO: K212618(Traditional)
ATTN: Geoffrey Pfeifer PHONE NO : 310 4874654
4400 MacArther Blvd., Ste. 900 SE DECISION MADE: 14-SEP-22
Newport Beach CA 92660 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Powder Free Nitrile Examination Glove
Dainam Glove Joint Stock Company 510(k) NO: K212751(Traditional)
ATTN: Damon Nguyen PHONE NO : 1 832 4584388
1765A Binh Duono Avenue, Hiep An WSE DECISION MADE: 24-SEP-22
Thu DAu Mot VN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AllureTM Surgical Mask
Allure Gift Wraps Private Limited 510(k) NO: K212926(Traditional)
ATTN: Mohan Jairam Raisinghani PHONE NO : 91 981 9837267
Plot No. J-21, J Type Area, 1st PhSE DECISION MADE: 16-SEP-22
Vapi IN 396195 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sterile Single-use LDV Syringe, CHOICARE Sterile Single-use LDV Syringe
Jeil Tech Co., Ltd. 510(k) NO: K213013(Traditional)
ATTN: Chun-Gi Lee PHONE NO : 82 44 8622656
190, Maesilro, Sojeongmyeon SE DECISION MADE: 19-SEP-22
Sejong-si KR 54001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Blood Pressure Monitor(Model:Y30001)
Zhangzhou Easepal Medical Science 510(k) NO: K213023(Traditional)
ATTN: Yuehua Huang PHONE NO : 86 189 05963518
West of the 4th Floor,No7. BuildinSE DECISION MADE: 30-SEP-22
Zhangzhou CN 363000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SpineAR SNAP
Surgical Theater, Inc. 510(k) NO: K213034(Traditional)
ATTN: Kevin Murrock PHONE NO : 330 4726520
30559 Pinetree Road, Suite 206 SE DECISION MADE: 29-SEP-22
Pepper Pike OH 44124 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP Mini-Mod, Compression Hip Screw (CHS), CONQUEST FN, and cannulated screws
Smith & Nephew Inc. 510(k) NO: K213126(Traditional)
ATTN: Thomas Fearnley PHONE NO : 901 3991224
1450 E Brooks Rd SE DECISION MADE: 29-SEP-22
Memphis TN 38116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Accusil Dental Impression Materials (Accusil Light Body Regular and Fast Set, Accusil Heavy Body Regular and Fast Set, Accusil Monophase Regular and Fast Set, Accusil Putty Regular and Fast Set, Accusil Bite Registration)
Prevest Denpro Limited 510(k) NO: K213244(Traditional)
ATTN: Atul Modi PHONE NO : 941 9194280
Export Promotion Industrial Park SE DECISION MADE: 09-SEP-22
Bari Brahmana IN 181133 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Dynamis Pro Family
Fotona d.o.o. 510(k) NO: K213267(Traditional)
ATTN: Marko Berdajs PHONE NO : 386 1 5009100
Stegne 7 SE DECISION MADE: 08-SEP-22
Ljubljana SI 1000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: StageOne Knee Cement Spacer Molds
Biomet, Inc. 510(k) NO: K213287(Traditional)
ATTN: Anuja Yardi PHONE NO : 862 5058612
56 East Bell Drive SE DECISION MADE: 02-SEP-22
Warsaw IN 46581 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: V-HEPES PLUS
Vitromed Langenfeld 510(k) NO: K213293(Traditional)
ATTN: Greg Holland PHONE NO : 949 2620411
Raoffeosemstr 15a SE DECISION MADE: 14-SEP-22
Langenfeld DE 40764 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DENU Composite Resin, DENU Flow Resin
HDI, Inc. 510(k) NO: K213339(Abbreviated)
ATTN: Taekyou Kim PHONE NO : 82 31 7353510
A-1504, 14, Sagimakgol-ro, 45 BeonSE DECISION MADE: 23-SEP-22
Seongnam-si KR 13209 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Aorta-CAD
Imagen Technologies, Inc 510(k) NO: K213353(Traditional)
ATTN: Robert Lindsey PHONE NO : 917 8304721
151 West 26th Street, Suite 1001 SE DECISION MADE: 20-SEP-22
New York NY 10001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Clearblue ® Early Pregnancy Test
SPD Swiss Precision Diagnostics Gm510(k) NO: K213379(Traditional)
ATTN: Joanne Scaife PHONE NO : 41 580047345
47 Route de Saint Georges, Petit-LSE DECISION MADE: 21-SEP-22
Geneva CH CH-1213 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ghost Spacer System
Life Spine, Inc. 510(k) NO: K213417(Traditional)
ATTN: Angela Batker PHONE NO : 847 8846117
13951 S. Quality Drive SE DECISION MADE: 29-SEP-22
Huntley IL 60142 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Female IC (Not Finalized)
Hollister Incorporated 510(k) NO: K213575(Traditional)
ATTN: Michelle Schiltz-Taing PHONE NO : 224 8640431
2000 Hollister Drive SE DECISION MADE: 13-SEP-22
Libertyville IL 60048 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LUOFUCON Collagen Wound Dressing
Huizhou Foryou Medical Devices CO.510(k) NO: K213598(Traditional)
ATTN: Taylor Deng PHONE NO : 86 752 5302185
No.1 Shangxia North Road, DongjianSE DECISION MADE: 20-SEP-22
Huizhou CN 516000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MONDRIAN ALIF Cage with Supplementary Fixation Plate
CTL Medical Corporation 510(k) NO: K213641(Traditional)
ATTN: Sean Suh PHONE NO : 214 5455820
4550 Excel Pkwy Ste 300 SE DECISION MADE: 15-SEP-22
Addison TX 75001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CellFX System
Pulse Biosciences, Inc. 510(k) NO: K213674(Traditional)
ATTN: Punam Gollamudi PHONE NO : 415 3054404
3957 Point Eden Way SE DECISION MADE: 22-SEP-22
Hayward CA 94545 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: InnovaBurn
Triad Life Sciences, Inc. 510(k) NO: K213716(Traditional)
ATTN: Bill Willis PHONE NO : 901 3336000
1770 Moriah Woods Blvd, Suite 18 SE DECISION MADE: 29-SEP-22
Memphis TN 38117 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: XACT Robotic System, ACE Model
XACT Robotics, Ltd. 510(k) NO: K213759(Traditional)
ATTN: Dan Sigal PHONE NO : 972 4 7700161
8 Hatochen Street, PO Box 3097 SE DECISION MADE: 23-SEP-22
Caesarea IL 3079861 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SP-CL Hip Stem and LCU Hip System
Waldemar Link GmbH & Co. KG 510(k) NO: K213770(Traditional)
ATTN: Pia Müller PHONE NO : 49 40 53995841
Oststrasse 4-10 SE DECISION MADE: 13-SEP-22
Norderstedt DE 22844 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SavvyWire
Opsens Inc. 510(k) NO: K213854(Traditional)
ATTN: Marc Chaunet PHONE NO : 418 7810333 3408
750 Boulevard du Parc TechnologiquSE DECISION MADE: 14-SEP-22
Québec CA G1P 4S3 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Arrow Pressure Injectable Midline Catheter
Arrow International LLC Subsidiary510(k) NO: K213855(Traditional)
ATTN: Kim Pennington PHONE NO : 610 4513095
3015 Carrington Mill Blvd SE DECISION MADE: 02-SEP-22
Morrisville NC 27560 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Identity Shoulder System
Zimmer Inc. 510(k) NO: K213856(Traditional)
ATTN: Patricia Sandborn Beres PHONE NO : 574 3765271
P.O Box 708 SE DECISION MADE: 15-SEP-22
Warsaw IN 46581-0708 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Bonebridge Osteosynthesis Plating System
Bonebridge AG 510(k) NO: K213864(Traditional)
ATTN: Christof Gerber PHONE NO : 41 794 587276
Bahnhofstrasse 11 SE DECISION MADE: 02-SEP-22
Zug CH 6300 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ASAHI Gladius Mongo18 PV ES
Asahi Intecc Co., LTD. 510(k) NO: K213868(Traditional)
ATTN: Tomoya Eguchi PHONE NO : 81 561 561859
3-100 Akatsuki-Cho SE DECISION MADE: 06-SEP-22
Seto JP 489-0071 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NanoZoomer S360MD Slide scanner system
Hamamatsu Photonics K.K. 510(k) NO: K213883(Traditional)
ATTN: Shinichi Fujisaka PHONE NO : 81 53 4310155
812, Joko-cho, Higashi-ku SE DECISION MADE: 27-SEP-22
Hamamatsu City JP 431-3196 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Pro M Class
Saeyang Microtech Co., Ltd. 510(k) NO: K213897(Traditional)
ATTN: Chang Hun Jeon PHONE NO : 82 53 5507566
348, Seongseo-ro SE DECISION MADE: 19-SEP-22
Daegu KR 41065 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Kerecis Oral
Kerecis 510(k) NO: K213904(Traditional)
ATTN: Gudmundur Fertram SigurjonssPHONE NO : 011 354 4198000
Eyrargata 2 SE DECISION MADE: 30-SEP-22
Isafjordur IS 400 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ultrasonic Endo Activation Device (Model:Actor I pro)
ChangZhou BoMedent Medical Technol510(k) NO: K213947(Traditional)
ATTN: Yang Chunyuan PHONE NO : 86 151 61150269
No.9 Changyang Road,West Taihu SciSE DECISION MADE: 08-SEP-22
Changzhou CN 213100 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LiverMultiScan v5 (LMSv5)
Perspectum 510(k) NO: K213960(Traditional)
ATTN: Wigley Ioan PHONE NO : 018 65 655343
Gemini One 5520 John Smith Drive SE DECISION MADE: 06-SEP-22
Oxford GB OX 2LL 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Eye Secret 59 UV Aspheric (Omafilcon A) Soft (Hydrophilic) Contact Lens for Daily Wear
Yung Sheng Optical Co., Ltd 510(k) NO: K213983(Traditional)
ATTN: Wen-Han Chen PHONE NO : 886 4 25658384 3509
No. 8, Keya 2nd Road, Daya DistricSE DECISION MADE: 02-SEP-22
Taichung City TW 428 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cranial EM System
Brainlab AG 510(k) NO: K213989(Traditional)
ATTN: Chiara Cunico PHONE NO : 49 899 915680
Olof-Palme-Str. 9 SE DECISION MADE: 08-SEP-22
Munich DE 81829 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Palm NRG cellulite body device (model: Palm NRG body device)
Heat In A Click LLC. 510(k) NO: K214015(Traditional)
ATTN: Guy Levi PHONE NO : 954 5189777
1975 Tigertail Blvd SE DECISION MADE: 26-SEP-22
Dania FL 33004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SOFIA 88 Catheter
MicroVention, Inc. 510(k) NO: K214024(Traditional)
ATTN: Alick Tan PHONE NO : 949 6152603
35 Enterprise SE DECISION MADE: 12-SEP-22
Aliso Viejo CA 92656 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICOR Lens Fragmentation System
Carl Zeiss Meditec Cataract Techno510(k) NO: K214028(Traditional)
ATTN: Gary Mocnik PHONE NO : 949 4330413
8748 Technology Way SE DECISION MADE: 09-SEP-22
Reno NV 89521 510(k) STATEMENT
DEVICE: LAITEST Medical Face Mask
R&R Medical Corporation Ltd 510(k) NO: K214035(Traditional)
ATTN: Wilson Chang PHONE NO : 886 2 26976618
No.4, Ln. 38, Zhongxing N. St., SaSE DECISION MADE: 13-SEP-22
New Taipei TW 24158 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Millipede 088 Access Catheter
Perfuze Ltd. 510(k) NO: K214048(Traditional)
ATTN: Anne-Marie Gannon PHONE NO : 353 91 428083
Unit 6, Galway Business Park, DangSE DECISION MADE: 20-SEP-22
Galway IE H91 W7CP 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Nitrile Inspection Gloves (Tested for Use with Chemotherapy Drugs)
Mezorrison Medical Technology (Don510(k) NO: K214056(Traditional)
ATTN: Ping Chen PHONE NO : 86 135 28734536
Room 202, No. 166 of East Campus, SE DECISION MADE: 20-SEP-22
Dongying CN 257000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LANDMARK REBOA Catheter
Zien Medical Technologies, Inc. 510(k) NO: K214060(Traditional)
ATTN: Tim Nieman PHONE NO : 801 8918610
2757 South 300 West Suite F SE DECISION MADE: 19-SEP-22
Salt Lake City UT 84115 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRANBERG Thermoguide Therapy System
Clinical Laserthermia Systems AB 510(k) NO: K214125(Traditional)
ATTN: Dan Mogren PHONE NO : 46 070 5901140
Scheelevägen 2 SE DECISION MADE: 22-SEP-22
Lund SE 22381 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Dexus Prosthetics System (Model: MSL1, MSR1)
Zhejiang Qiangnao Technology Co.,L510(k) NO: K220002(Traditional)
ATTN: Boyuan Meng PHONE NO : 86 158 14407855
Room 201-5, Building 1, No.1818-2,SE DECISION MADE: 09-SEP-22
Hangzhou CN 310000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CogNet QmTRIAGE
MedCognetics, Inc. 510(k) NO: K220080(Traditional)
ATTN: Diane Rutherford PHONE NO : 214 3906569
17217 Waterview Parkway Suite 1.20SE DECISION MADE: 29-SEP-22
Dallas TX 75252 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CORE-SPORT
Incore Co., Ltd. 510(k) NO: K220081(Traditional)
ATTN: Lee Jae-Hun PHONE NO : 82 2 8663514
11, Hyeoksin-daero, 78-gil, Dong-gSE DECISION MADE: 28-SEP-22
Daegu KR 41072 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Infrared Forehead Thermometer
Qingdao Yasee Medical Device Co., 510(k) NO: K220084(Third Party - Traditional)
ATTN: Shaoju Tian PHONE NO : 86 133 41254319
No.9 Xiuyuan Road, High-tech IndusSE DECISION MADE: 12-SEP-22
Qingdao CN 266112 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: Disposable Polyp Snare
Jiangsu Vedkang Medical Science an510(k) NO: K220089(Traditional)
ATTN: Tang Ting PHONE NO : 86 519 69877755
No. 52, Guoxiang Road, Wujin EconoSE DECISION MADE: 22-SEP-22
Changzhou CN 213149 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Knee+
Pixee Medical 510(k) NO: K220104(Traditional)
ATTN: Lucie Pecheur PHONE NO : 33 4 58101365
18 rue Alain Savary SE DECISION MADE: 01-SEP-22
Besancon FR 25000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AXIOS Stent and Electrocautery-Enhanced Delivery System
Boston Scientific Corporation 510(k) NO: K220112(Traditional)
ATTN: Ian Broome PHONE NO : 508 9425571
100 Boston Scientific Way SE DECISION MADE: 07-SEP-22
Marlborough MA 01752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Auryon Atherectomy Catheters
Eximo Medical Ltd. 510(k) NO: K220116(Traditional)
ATTN: Yoel Zabar PHONE NO : 972 8 6307639
Pekeris St 3 SE DECISION MADE: 26-SEP-22
Rehovot IL 7670203 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Promisemed X-Safety Pen Needle
Promisemed Hangzhou Meditech Co., 510(k) NO: K220129(Traditional)
ATTN: Zearou Yang PHONE NO : 86 571 88772985
No. 1388 Cangxing Street, CangqianSE DECISION MADE: 19-SEP-22
Hangzhou City CN 311121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: cobas pure integrated solutions, Glucose HK Gen.3, ISE indirect Na for Gen.2, ONLINE DAT Methadone II, Elecsys TSH
Roche Diagnostics 510(k) NO: K220134(Traditional)
ATTN: Noel Mencias PHONE NO : 463 3362546
9115 Hague Road SE DECISION MADE: 16-SEP-22
Indianapolis IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BARBIE (polymacon) Daily Wear Soft (Hydrophilic) Contact Lens
Shenzhen Dashicheng Optical Techno510(k) NO: K220143(Traditional)
ATTN: Jiayi Li PHONE NO : 86 136 32966073
101, 201 and 301, Unit 3, BuildingSE DECISION MADE: 08-SEP-22
Shenzhen CN 518110 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Elecsys AFP
Roche Diagnostics 510(k) NO: K220176(Traditional)
ATTN: Jamie Ferguson PHONE NO : 317 2707402
9115 Hague Road SE DECISION MADE: 15-SEP-22
Indianapolis IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Magnus Neuromodulation System (MNS) with SAINT Technology, Model Number 1001K
Magnus Medical, Inc. 510(k) NO: K220177(Traditional)
ATTN: Brett Wingeier PHONE NO : 415 6907358
1350 Old Bayshore Highway Suite 60SE DECISION MADE: 01-SEP-22
Burlingame CA 94010 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: V-Print dentbase
Voco GmbH 510(k) NO: K220236(Traditional)
ATTN: M. Th. Plaumann PHONE NO : 49 4721 7190
Anton-Flettner-Str. 1-3 SE DECISION MADE: 21-SEP-22
Cuxhaven DE 27472 510(k) STATEMENT
DEVICE: Solid State X-ray Imager(Model: FXRD-4386WB)
Vieworks Co., Ltd. 510(k) NO: K220239(Traditional)
ATTN: Kevin Oh PHONE NO : 82 70 44663220
41-3, Burim-ro 170beon-gil, DonganSE DECISION MADE: 13-SEP-22
Anyang-si KR 14055 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Pocket Fetal Doppler (Models CONTEC10C and CONTEC10CL)
Contec Medical Systems Co., Ltd. 510(k) NO: K220245(Traditional)
ATTN: Jie Xiao PHONE NO : 86 335 8015490
No.112 Qinhuang West Street, EconoSE DECISION MADE: 28-SEP-22
Qinhuangdao CN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Neodent Implant System - GM Narrow Implant System
JJGC Industria e Comercio de Mater510(k) NO: K220251(Traditional)
ATTN: Mariana Soares Hartmann PHONE NO : 55 41 21694000
Av. Juscelino Kubitschek de OliveiSE DECISION MADE: 06-SEP-22
Curitiba BR 81270-200 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: True Tulip, True M.I.S.
Innovative Surgical Designs, Inc. 510(k) NO: K220297(Traditional)
ATTN: Jon Rinehart PHONE NO : 217 8368522
3903 S. Walnut St. SE DECISION MADE: 16-SEP-22
Bloomington IN 47401 510(k) STATEMENT
DEVICE: Soundly Anti Snoring Device
Greystone IP Ltd 510(k) NO: K220330(Abbreviated)
ATTN: Judy Purvis PHONE NO : 44 751 5788487
Unit 322, Moat House, 54 BloomfielSE DECISION MADE: 08-SEP-22
Belfast IE BT5 5AD 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Mg-PSZ Ceramic Femoral Head
Theken Companies 510(k) NO: K220336(Special)
ATTN: Garrett Spurgeon PHONE NO : 330 7337600
1800 Triplett Blvd SE DECISION MADE: 30-SEP-22
Akron OH 44306 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Esthetic Abutments Nobel Biocare N1
Nobel Biocare Services AG 510(k) NO: K220339(Traditional)
ATTN: Bernice Jim PHONE NO : 41 779 8550073
Balz Zimmermann-Str. 7 SE DECISION MADE: 16-SEP-22
Kloten CH 8302 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.3
Canon Medical Systems Corporation 510(k) NO: K220342(Traditional)
ATTN: Paul Biggins PHONE NO : 951 3137400
1385 Shimoishigami SE DECISION MADE: 27-SEP-22
Otawara-shi JP 324-8550 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Tandry Compression Screw System
Microware Precision Co., Ltd. 510(k) NO: K220359(Traditional)
ATTN: Harrison Du PHONE NO : 886 4 24636275 100
No. 12, Keyuan 2nd Rd., Situn DistSE DECISION MADE: 20-SEP-22
Taichung TW 40763 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EmbedMed
3D LifePrints UK Ltd. 510(k) NO: K220366(Traditional)
ATTN: Henry Pinchbeck PHONE NO : 44 079 71172273
The Innovation Hub, Alder Hey ChilSE DECISION MADE: 30-SEP-22
West Derby, Liverpool, Merseyside 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Esthetic Colorant
Kuraray Noritake Dental Inc. 510(k) NO: K220369(Traditional)
ATTN: Yasujiro Ohara PHONE NO : 81 3 67011736
Tokiwabashi Tower, 2-6-4, OtemachiSE DECISION MADE: 23-SEP-22
Chiyoda-ku JP 100-0004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Tornier Perform Humeral System – Stemless
Tornier, Inc. 510(k) NO: K220418(Traditional)
ATTN: Renee Stoffel PHONE NO : 952 6837471
10801 Nesbitt Ave South SE DECISION MADE: 14-SEP-22
Bloomington MN 55437 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CYGNUS™ MoRe Anterior Cervical Plate System
MiRus, LLC 510(k) NO: K220441(Traditional)
ATTN: Jordan Bauman PHONE NO : 404 3458235
1755 West Oak Parkway, Suite 100 SE DECISION MADE: 16-SEP-22
Marietta GA 30062 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Platform® Acetabular System
Total Joint Orthopedics, Inc. 510(k) NO: K220483(Traditional)
ATTN: Chris Weaber PHONE NO : 801 4866070
1567 E. Stratford Avenue SE DECISION MADE: 23-SEP-22
Salt Lake City UT 84106 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FOX 810, FOX 980
A.R.C. Laser GmbH 510(k) NO: K220531(Traditional)
ATTN: Angela Thyzel PHONE NO : 09 11 217790
Bessemer St. 14 SE DECISION MADE: 01-SEP-22
Nurnberg DE 90411 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ProGrip Self-Gripping Polypropylene Mesh
Covidien 510(k) NO: K220540(Special)
ATTN: Jonas Gulmez PHONE NO : 857 2226125
15 Hampshire Street SE DECISION MADE: 22-SEP-22
Mansfield MA 02048 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Neuro Omega System, NeuroSmart System
Alpha Omega Engineering Ltd. 510(k) NO: K220553(Special)
ATTN: Efrat Shamgar PHONE NO : 972 54 5616253
Hamerkava St.6, Tsiporit IndustriaSE DECISION MADE: 16-SEP-22
Nof HaGalil (Nazareth Illit) IL 1510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ambient HipVac 50 Wand with Integrated Finger Switches, RF20000 COBLATION System, WEREWOLF COBLATION System, WEREWOLF+ COBLATION System
Arthrocare Corporation 510(k) NO: K220563(Traditional)
ATTN: Alexander Brankner PHONE NO : 512 6733090
7000 West William Cannon Drive BuiSE DECISION MADE: 01-SEP-22
Austin TX 78735 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Easi-Vue embolic microspheres System
ABK Biomedical Inc 510(k) NO: K220567(Traditional)
ATTN: Brandi Woods PHONE NO : 919 6196417
155 Chain Lake Drive Unit 32 SE DECISION MADE: 07-SEP-22
Halifax CA B3S 1B3 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Hybrid C70
Digimed Co., Ltd 510(k) NO: K220579(Traditional)
ATTN: Youngbae Kwon PHONE NO : 82 2 26241551
309-311, 318-ho 145, Gasan digitalSE DECISION MADE: 01-SEP-22
Seul KR 08506 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NeoNavia Biopsy System
NeoDynamics AB 510(k) NO: K220595(Traditional)
ATTN: Anna Forsberg PHONE NO : 973 9539885
Lejonvagen 14 SE DECISION MADE: 08-SEP-22
Lidingo SE SE-181 32 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD MAX Enteric Viral Panel
Becton, Dickinson and Company 510(k) NO: K220607(Traditional)
ATTN: Joseph Basore PHONE NO : 616 3014068
7 Loveton Circle SE DECISION MADE: 21-SEP-22
Sparks MD 21152 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AUTOBAHN(R) EVO Femoral Nails
Globus Medical Inc. 510(k) NO: K220659(Traditional)
ATTN: Jennifer Antonacci PHONE NO : 610 9301800 1861
2560 General Armistead Ave. SE DECISION MADE: 09-SEP-22
Audubon PA 19403 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Talee, Talee PostOP
Invent Medical USA, LLC 510(k) NO: K220681(Traditional)
ATTN: Jiri Rosicky PHONE NO : 1 267 3688165
1800 Mearns Rd, Suite Y SE DECISION MADE: 22-SEP-22
Warminster PA 18974 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nitrile Patient Examination Gloves, Powder Free
Lalan Rubbers (Pvt) Ltd 510(k) NO: K220697(Traditional)
ATTN: Renuka Priyangi PHONE NO : 0094 716 852746
No.95/B, Zone A, Export ProcessingSE DECISION MADE: 15-SEP-22
Malwana LK EPZ 11672 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: e-Ortho Shoulder Software v1.1
FH Industrie 510(k) NO: K220758(Traditional)
ATTN: Oscar Ramirez PHONE NO : 33 2 98556895
ZI de Kernevez - 6 rue Nobel SE DECISION MADE: 30-SEP-22
Quimper FR 29000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: syngo.via RT Image Suite
Siemens Medical Solutions USA Inc.510(k) NO: K220783(Special)
ATTN: Clayton Ginn PHONE NO : 865 8982692
810 Innovation Drive SE DECISION MADE: 07-SEP-22
Knoxville TN 37932 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Clean Connecting Tube
Yangzhou Fartley Medical Instrumen510(k) NO: K220785(Traditional)
ATTN: Tina Han PHONE NO : 0086 1505 1101225
Beizhou Road, Lidian Town, GuangliSE DECISION MADE: 27-SEP-22
Yangzhou CN 225106 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QT ECG
QT Medical, Inc. 510(k) NO: K220795(Traditional)
ATTN: Jackal Chen PHONE NO : 1 909 3230007
1360 Valley Vista Drive, Suite 203SE DECISION MADE: 26-SEP-22
Diamond Bar CA 91765 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TrueBalance™ Surgical System
These Three Medical, LLC 510(k) NO: K220830(Traditional)
ATTN: Moj Eram PHONE NO : 801 2308611
20860 N. Tatum Blvd., Suite 300 SE DECISION MADE: 15-SEP-22
Phoenix AZ 85050 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Dental Implantation Systems, Dental Electrical Motors
Foshan COXO Medical Instrument Co.510(k) NO: K220831(Traditional)
ATTN: Yongjian Zheng PHONE NO : 86 1370 2544788
BLDG 4, Dist A, Guangdong New LighSE DECISION MADE: 27-SEP-22
Foshan CN 528226 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Arthrex Compression FT Pins
Arthrex Inc. 510(k) NO: K220839(Traditional)
ATTN: Rebecca R. Homan PHONE NO : 1 239 6435553 73429
1370 Creekside Boulevard SE DECISION MADE: 19-SEP-22
Naples FL 34108-1945 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Powder Free Nitrile Examination Gloves, Colored (Green, Orange, Purple, White, & Black)
Careglove Global SDN BHD 510(k) NO: K220859(Traditional)
ATTN: Lim Kwee Shyan PHONE NO : 60 6 6782377
Lot 17479, Lorong Senawang 2/3, OfSE DECISION MADE: 09-SEP-22
Seremban MY 70450 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Matreneu Percutaneous Balloon Compression Kit
Shenzhen Shineyard Medical Device 510(k) NO: K220920(Traditional)
ATTN: Yan Ping PHONE NO : 86 755 26912231
3F, Changfeng Industrial Block No.SE DECISION MADE: 07-SEP-22
Shenzhen CN 518000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HotDog Temperature Management System
Augustine Temperature Management 510(k) NO: K220941(Traditional)
ATTN: Garrett Augustine PHONE NO : 952 4653529
7656 West 78th Street SE DECISION MADE: 23-SEP-22
Minneapolis MN 55439 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PointCore Surgical Mask
PointCore, Inc. 510(k) NO: K220944(Traditional)
ATTN: William Christiansen PHONE NO : 309 3085152
124 SW Adams SE DECISION MADE: 09-SEP-22
Peoria IL 61602 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ChoiceSpine TigerShark™ M, Modular Interbody System
ChoiceSpine, LLC 510(k) NO: K220953(Traditional)
ATTN: Kim Finch PHONE NO : 865 2433969
400 Erin Drive SE DECISION MADE: 13-SEP-22
Knoxville TN 37919 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ROTAPRO Rotational Atherectomy System
Boston Scientific Corporation 510(k) NO: K220962(Traditional)
ATTN: Heather Schuchard PHONE NO : 763 4942537
One Scimed Place SE DECISION MADE: 06-SEP-22
Maple Grove MN 55311 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GelPOINT V-Path Vaginal Access System
Applied Medical Resources Corporat510(k) NO: K220969(Traditional)
ATTN: David Yu PHONE NO : 949 7138023
22872 Avenida Empresa SE DECISION MADE: 16-SEP-22
Rancho Santa Margarita CA 92688 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TSX Implants
Biomet 3i LLC 510(k) NO: K220978(Traditional)
ATTN: Mariela Cabarcas PHONE NO : 561 7766700
4555 Riverside Drive SE DECISION MADE: 14-SEP-22
Palm Beach Gardens FL 33410 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SprintRay Denture Base
SprintRay Inc 510(k) NO: K220979(Traditional)
ATTN: Sara Moghtadernejad PHONE NO : 917 9123858
2705 Media Center Drive, Suite 100SE DECISION MADE: 14-SEP-22
Los Angeles CA 90065 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Aquilion Precision (TSX-304A/4) V10.10 with AiCE
Canon Medical Systems Corporation 510(k) NO: K220986(Traditional)
ATTN: Paul Biggins PHONE NO : 714 6697808
1385 Shimoishigami SE DECISION MADE: 12-SEP-22
Otawara-shi JP 324-8550 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Qorda QD1
Winix Inc. 510(k) NO: K220990(Traditional)
ATTN: Daewoon Kang PHONE NO : 82 31 51807575
80-13, Sujeong-ro, Jangan-myeon SE DECISION MADE: 14-SEP-22
Hwaseong-si KR 18583 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Wireless TENS/EMS, Bruno, Aela
ZMI Elecronics Ltd. 510(k) NO: K220997(Traditional)
ATTN: Lawerence Liu PHONE NO : 886 7 8150053 351
6F-1, 286-4, Shin Ya Road SE DECISION MADE: 01-SEP-22
Kaohsiung TW 806 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Autosuture EEA Stapler / circular stapler with DST Series Technology / EEA Autosuture Circular Stapler with DST Series Technology / DST Series EEA Stapler / DST EEA
Covidien 510(k) NO: K221003(Traditional)
ATTN: Sanja Jahr PHONE NO : 203 4928415___
60 Middletown Avenue SE DECISION MADE: 30-SEP-22
North Haven CT 06473 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Medical Masks
Hantech Medical Device Co., Ltd. 510(k) NO: K221038(Third Party - Traditional)
ATTN: Arnold Yang PHONE NO : 86 189 17368988
No 288, Sanheng Road Changhe IndusSE DECISION MADE: 01-SEP-22
Ningbo CN 315326 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: RIGHTEST Lancing Device GD500, GE Lancing Device, iGlucose Lancing Device
Bionime Corporation 510(k) NO: K221062(Traditional)
ATTN: Yu Chi Huang PHONE NO : 886 4 23692388 5898
No. 100, Section 2, Daqing Street.SE DECISION MADE: 26-SEP-22
Taichung City TW 40242 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OptaBlate RF Generator, OptaBlate Probes, OptaBlate Microinfuser Infusion Device
Stryker Corporation 510(k) NO: K221074(Traditional)
ATTN: Bruce Backlund PHONE NO : 1 763 7625902
1941 Stryker Way SE DECISION MADE: 16-SEP-22
Portage MI 49002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LiNA OperaScope Needle
LiNA Medical ApS 510(k) NO: K221085(Traditional)
ATTN: Jaroslaw Mrówczynski PHONE NO : 48 61 2228654
Formervangen 5 SE DECISION MADE: 02-SEP-22
Glostrup DK 2600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: P12 Elite Series Digital Color Doppler Ultrasound System
Sonoscape Medical Corp. 510(k) NO: K221089(Traditional)
ATTN: Toki Wu PHONE NO : 86 755 26722890
Room 201&202, 12th Building, ShenzSE DECISION MADE: 15-SEP-22
Shenzhen CN 518057 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Transcutaneous Electrical Nerve Stimulator Model: ST-304
Shenzhen Future Electronic Co., Lt510(k) NO: K221092(Traditional)
ATTN: Zhao Qihong PHONE NO : 86 134 10947296
Bldg B. Qiangchengda Industrial PaSE DECISION MADE: 13-SEP-22
Shenzhen CN 518116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: P20 Elite Series Digital Color Doppler Ultrasound System
Sonoscape Medical Corp. 510(k) NO: K221140(Traditional)
ATTN: Toki Wu PHONE NO : 86 755 26722890
Room 201&202, 12th Building, ShenzSE DECISION MADE: 13-SEP-22
Shenzhen CN 518057 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SomnoMetry
Neumetry Medical Inc 510(k) NO: K221179(Traditional)
ATTN: Paul Chen PHONE NO : 925 9979560
47102 Mission Falls Ct. Suite 210 SE DECISION MADE: 21-SEP-22
Fremont CA 94539 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LEDEX
Dentmate Technology Co. Ltd. 510(k) NO: K221194(Abbreviated)
ATTN: Cheng-Feng Chou PHONE NO : 886 2897 69226
8F, No.8-11, Sec. 1, Zhongxing RoaSE DECISION MADE: 16-SEP-22
New Taipei TW 24872 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Infrared thermometer
Shenzhen Yolanda Technology Co., L510(k) NO: K221211(Traditional)
ATTN: Baihua Han PHONE NO : 86 158 11815862
Room 201, Jinfulai Building, No.49SE DECISION MADE: 27-SEP-22
Shenzhen CN 518101 510(k) STATEMENT
DEVICE: Hand-held IPL device (IPL Home Use Hair Removal Device) Model:FZ-608, FZ-608G, FZ-100, FZ-200
Shenzhen IONKA Medical Technology 510(k) NO: K221214(Traditional)
ATTN: Chen Dongfa PHONE NO : 86 755 23406031
Room 601, No. 3, Jiazitang Second SE DECISION MADE: 21-SEP-22
Shenzhen CN 518123 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Tuttnauer Horizontal autoclave series model: 4472, 5596, 6690, 66120
Tuttnauer Ltd. 510(k) NO: K221227(Traditional)
ATTN: Robert Basile PHONE NO : 631 7374850
Har-Tuv Industrial Zone SE DECISION MADE: 20-SEP-22
Beit-Shemesh IL 9910101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DrAid for Radiology v1
VinBrain Joint Stock Company 510(k) NO: K221241(Traditional)
ATTN: Nguyen Nhat Linh PHONE NO :
No 7 Bang Lang 1 Street, Vinhomes SE DECISION MADE: 01-SEP-22
Viet Hung Ward, Long Bien District510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OFNat Lubricant (L15)
Suretex Limited 510(k) NO: K221243(Traditional)
ATTN: KC Nguyen PHONE NO : 66 77 277400
31/1 Moo 4, Suratthani-Thakuapha RSE DECISION MADE: 30-SEP-22
Tambon Khao Hua Kwai, Amphur Phunp510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: L1P-1F (TRIOS 5)
3Shape TRIOS A/S 510(k) NO: K221249(Traditional)
ATTN: Klaus Rudbaek Hoj PHONE NO : 45 31 488032
Holmens Kanal 7 SE DECISION MADE: 16-SEP-22
Copenhagen K DK Dk-1060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Mygen M-3004 RF Generator M-3004
RF Medical Co., Ltd 510(k) NO: K221277(Traditional)
ATTN: Kwang S Choi PHONE NO : 82 2 21084200
#502, 503, 506, 511, 254, BeotkkotSE DECISION MADE: 02-SEP-22
Seoul KR 08511 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Hammertoe Truss System (HTS)
4WEB Medical, Inc. 510(k) NO: K221283(Traditional)
ATTN: Lewis Harrison PHONE NO : 800 2857090
2801 Network Blvd., Suite 620 SE DECISION MADE: 06-SEP-22
Frisco TX 75034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Consona N9, Consona N9 Pro, Consona N9 Super, Consona Nova, Consona N9S, Consona NI, Consona NT, Nuewa N9, Recho N9, Consona N9 Exp, Consona N9 Elite, Resona N9, Consona N9T, Consona N8, Consona N8 Pro, Consona N8 Super, Consona OR, Consona N8S, Consona OI, Consona OT, Consona N8 Exp, Consona N8 Elite, Consona N8T, Consona N7, Consona N7 Pro, Consona N7 Super, Consona VR, Consona N7S, Consona VI, Consona VT, Consona N7 Exp, Consona N7 Elite, Consona N7T Diagnostic Ultrasound System
Shenzhen Mindray Bio-Medical Elect510(k) NO: K221300(Traditional)
ATTN: Zhang Wei PHONE NO : 86 755 81885655
Keji 12th Road South, Hi-tech InduSE DECISION MADE: 29-SEP-22
Shenzhen CN 518057 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Endoscope Valves System
Changzhou Endoclean Medical Device510(k) NO: K221331(Traditional)
ATTN: Wang Qi PHONE NO : 86 0519 68213060
West Side of 4th Floor, Building ESE DECISION MADE: 08-SEP-22
Changzhou CN 213149 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ECHELON ENDOPATH Staple Line Reinforcement
Ethicon Endo-Surgery LLC 510(k) NO: K221343(Traditional)
ATTN: Rubina Dosani PHONE NO : 513 3373566
475 Calle C SE DECISION MADE: 16-SEP-22
Guaynabo PR 00696 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Arthrex SutureTape
Arthrex Inc. 510(k) NO: K221354(Special)
ATTN: Lai Saeteurn PHONE NO : 1 239 5984302 71764
1370 Creekside Boulevard SE DECISION MADE: 09-SEP-22
Naples FL 34108-1945 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Medline UNITE® Medial Malleolus Peg Plate System
Medline Industries, LP 510(k) NO: K221360(Traditional)
ATTN: Jennifer Mason PHONE NO : 847 6433652
Three Lakes Drive SE DECISION MADE: 27-SEP-22
Northfield IL 60093 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CureSight-CS100
NovaSight Ltd. 510(k) NO: K221375(Traditional)
ATTN: Ran Yam PHONE NO : 972 3 6422868
1 Hayarden St. SE DECISION MADE: 29-SEP-22
Airport City IL 7019801 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nitrile Powder Free Blue Patient Examination Gloves, Non-Sterile
Tec Gloves Industry (M) Sdn.Bhd. 510(k) NO: K221378(Traditional)
ATTN: Eunice Arumugam PHONE NO : 60 19 3121218
Lot 35793, Jalan Sungai Batu 31/KUSE DECISION MADE: 30-SEP-22
Klang MY 42100 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MedtFine Blood Lancet
Shanghai Carelife International Tr510(k) NO: K221383(Traditional)
ATTN: Zhang Xiaoying PHONE NO : 86 2158 542656
1707 Yinqiao Bldg.,58 Jinxin Rd.20SE DECISION MADE: 21-SEP-22
Shanghai CN 201206 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NuVasive Reline Cervical System
NuVasive, Incorporated 510(k) NO: K221388(Traditional)
ATTN: Sali Gully PHONE NO : 858 9093360
7475 Lusk Blvd. SE DECISION MADE: 09-SEP-22
San Diego CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MitraClip G4 Steerable Guide Catheter
Abbott Medical 510(k) NO: K221397(Special)
ATTN: Cynthia Aguirre PHONE NO : 480 2841629
177 Country Road B East SE DECISION MADE: 28-SEP-22
Saint Paul MN 55117 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENROUTE Enflate Transcarotid RX Balloon Dilatation Catheter
Silk Road Medical, Inc. 510(k) NO: K221414(Traditional)
ATTN: Denise Aycox PHONE NO : 408 5852156
1213 Innsbruck Drive SE DECISION MADE: 02-SEP-22
Sunnyvale CA 94089 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CLAROX plus (Model: VX-100)
VSI Co., Ltd. 510(k) NO: K221417(Traditional)
ATTN: Jake Yu PHONE NO : 82 43 2679039
151-33, Namseok-ro Nami-myeon, SeoSE DECISION MADE: 13-SEP-22
Cheongju-si KR 28182 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Primary Relief
DyAnsys, Inc. 510(k) NO: K221425(Traditional)
ATTN: Srini Nageshwar PHONE NO : 408 4804700
300, North Bayshore Boulevard SE DECISION MADE: 13-SEP-22
San Mateo CA 94401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Phosphoric Acid Etching Gel
Rizhao HuGe Biomaterials Company, 510(k) NO: K221450(Traditional)
ATTN: Maggie Zheng PHONE NO : 086 633 2277268
No.2 North Zhaoyang Road, DistrictSE DECISION MADE: 12-SEP-22
Rizhao City CN 276800 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Rapid ICH
iSchemaView Inc. 510(k) NO: K221456(Traditional)
ATTN: James Rosa PHONE NO : 303 7043374
1120 Washington Ave., Ste 200 SE DECISION MADE: 12-SEP-22
Golden CO 80401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Flowart
Asset Medikal Tasarim AS. 510(k) NO: K221473(Traditional)
ATTN: Ebru Sirali PHONE NO : 902 124 942727
Ikitelli OSB Mahallesi, 17. Cadde,SE DECISION MADE: 26-SEP-22
Istanbul TR 34490 510(k) STATEMENT
DEVICE: NeutrArt
Asset Medikal Tasarim AS. 510(k) NO: K221481(Traditional)
ATTN: Ebru Sirali PHONE NO : 90 212 4942727
Ikitelli OSB Mahallesi, 17. Cadde,SE DECISION MADE: 23-SEP-22
Istanbul TR 34490 510(k) STATEMENT
DEVICE: Consona N6, Consona N6 Pro, Consona N6 Super, Consona AR, Consona N6S, Consona AE, Consona AT, Consona N6 Exp Diagnostic Ultrasound System, Consona N6 Elite, Consona N6T Diagnostic Ultrasound System
Shenzhen Mindray Bio-medical Elect510(k) NO: K221496(Traditional)
ATTN: Zhang Wei PHONE NO : 86 755 81885655
Keji 12th Road South, Hi-tech InduSE DECISION MADE: 29-SEP-22
Shenzhen CN 518057 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Plasma Shield
Plasmatica LTD 510(k) NO: K221533(Traditional)
ATTN: Adam Sagiv PHONE NO : 972 52 2232562
HaTa'asiya St. 25 SE DECISION MADE: 12-SEP-22
Ra'anana IL 4365413 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Surgical Face Masks (Ear Loops And Tie-On)
San-M Package Co., Ltd. 510(k) NO: K221534(Traditional)
ATTN: Akihiko Goto PHONE NO : 011 81547 454125
1086-1 Ojiro SE DECISION MADE: 16-SEP-22
Shimada-city JP 428-8652 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Dental Air Polishing Handpiece
Guilin Woodpecker Medical Instrume510(k) NO: K221548(Traditional)
ATTN: Xunxian Wu PHONE NO : 86 773 2350532
Information Industrial Park, GuiliSE DECISION MADE: 28-SEP-22
Guilin City CN 541004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Diamond Air+ (UI04A, UI04B, UI04C)
Ulike Co., Ltd 510(k) NO: K221553(Special)
ATTN: Lin Xiaoming PHONE NO : 86 159 15373017
2, Myeongdong, 6-gil, Jung-gu SE DECISION MADE: 15-SEP-22
Seoul KR 04535 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Visera Hysterovideoscope Olympus HYF Type V
Olympus Medical Systems Corporatio510(k) NO: K221557(Traditional)
ATTN: Toshio Nakamura PHONE NO : 81 42 6422694
2951 Ishikawa-cho, Hachioji-shi SE DECISION MADE: 02-SEP-22
Tokyo JP 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KOLO Evolution XHD Series Ultrasound Diagnostic System
Kolo Medical (Suzhou) Co., Ltd 510(k) NO: K221568(Traditional)
ATTN: Mike SU PHONE NO : 86 138 62426770
Room 303-305 and 504, Building A5,SE DECISION MADE: 12-SEP-22
Suzhou CN 215123 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CO2 Laser System
Smedtrum Medical Technology Co., L510(k) NO: K221597(Traditional)
ATTN: Crimson Wu PHONE NO : 886 2 22989578 301
1F., No. 8, Ln. 97, Wugong Rd., SE DECISION MADE: 15-SEP-22
New Taipei City TW 248016 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Tracheal Intubation Fiberscope OLYMPUS LF-P, VISERA Tracheal Intubation Videoscope OLYMPUS LF Type V
Olympus Medical Systems Corp. 510(k) NO: K221631(Traditional)
ATTN: Shinichiro Kawachi PHONE NO : 81 42 6422694
2951 Ishikawa-cho Hichioji-shi SE DECISION MADE: 26-SEP-22
Tokyo JP 192-8507 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EMPHASYS Acetabular System
DePuy Ireland UC 510(k) NO: K221636(Traditional)
ATTN: Elaine Pears PHONE NO :
Loughbeg SE DECISION MADE: 06-SEP-22
Ringaskiddy IE 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Surgical Gown (Sterile); Surgical Gown (Non-sterile)
Allmed Medical (Hubei) Protective 510(k) NO: K221637(Traditional)
ATTN: Vince Tian PHONE NO : 86 717 4215906
No.29 Dong Hu Road, Majiadian TownSE DECISION MADE: 29-SEP-22
Zhijiang CN 443203 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Rhino-Laryngo Videoscope Olympus ENF-VH, Rhino-Laryngo Videoscope Olympus ENF-V3
Olympus Medical Systems Corp. 510(k) NO: K221638(Traditional)
ATTN: Shinichiro Kawachi PHONE NO : 81 42 6422697
2951 Ishikawa-cho SE DECISION MADE: 19-SEP-22
Hachioji-shi JP 192-8507 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Synthetic Bone Putty
Ventris Medical 510(k) NO: K221644(Traditional)
ATTN: John Brunelle PHONE NO : 949 7065551
1201 Dove Street, Suite 470 SE DECISION MADE: 02-SEP-22
Newport Beach CA 92660 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Exsalta
DRW Medical 510(k) NO: K221676(Traditional)
ATTN: Dan Tatum PHONE NO : 610 9965308
2710 Concord Road SE DECISION MADE: 16-SEP-22
Aston PA 19104 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Osstem Abutment System
Osstem Implant Co., Ltd. 510(k) NO: K221684(Traditional)
ATTN: Seungju Kang PHONE NO : 82 70 48710203
66-16, Bansong-ro 513beon-gil, HaeSE DECISION MADE: 08-SEP-22
Busan KR 48002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NovoSorb Matrix
PolyNovo Biomaterials Pty Ltd 510(k) NO: K221686(Special)
ATTN: Tarun Nekkenti PHONE NO : 61 042 2205041
2/320 Lorimer St SE DECISION MADE: 15-SEP-22
Port Melbourne AU 3207 510(k) STATEMENT
DEVICE: SafeSept® Transseptal Guidewire (SS-140)
Pressure Products Medical Device M510(k) NO: K221707(Special)
ATTN: Andrew Armour PHONE NO : 610 5432324
1 School Street SE DECISION MADE: 14-SEP-22
Morton PA 19070 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Surgical Gown UM-148
Unimax Medical Products Co., Ltd. 510(k) NO: K221717(Traditional)
ATTN: Haibo Ning PHONE NO : 86 027 82213162
No.1 Liansai Road, Changshangkou TSE DECISION MADE: 20-SEP-22
Xiantao CN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Polyisoprene Powder Free Surgical Glove Tested for Use with Chemotherapy Drugs (Natural)
Hartalega NGC SDN BHD 510(k) NO: K221718(Traditional)
ATTN: Kuan Mun Leong PHONE NO : 603 62771733
NO. 1, Persiaran Tanjung Kawasan PSE DECISION MADE: 24-SEP-22
Sepang MY 43900 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Conductive Gel
Tone-A-Matic International Inc. 510(k) NO: K221724(Traditional)
ATTN: Manuel Chuck PHONE NO : 905 5019290
145 Traders East Unit 18 SE DECISION MADE: 23-SEP-22
Mississauga CA L5Z-3L3 510(k) STATEMENT
DEVICE: FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire, FiberStitch Implant, Straight with two Polyester Implants and 2-0 FiberWire
T.A.G. Medical Products Corporatio510(k) NO: K221731(Traditional)
ATTN: Shlomi Dines PHONE NO : 972 4 9858400
SE DECISION MADE: 07-SEP-22
Gaaton IL 2513000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAGNETOM Sola, MAGNETOM Altea, MAGNETOM Sola Fit
Siemens Medical Solutions USA, Inc510(k) NO: K221733(Traditional)
ATTN: Alina Goodman PHONE NO : 1 317 3718593
40 Liberty Boulevard SE DECISION MADE: 13-SEP-22
Malvern PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NS-HGlio
Neosoma Inc. 510(k) NO: K221738(Traditional)
ATTN: Aly H Abayazeed PHONE NO : 443 804 8096
44 Farmers Row SE DECISION MADE: 27-SEP-22
Groton MA 01450 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Medispo Rubber Surgical Gloves, Medispo Polyisoprene Surgical Gloves
Guilin HBM Health Protections, Inc510(k) NO: K221748(Traditional)
ATTN: Pu Lei PHONE NO : 86 1370 7738532
No.1-2, Shuijing East Road EconomiSE DECISION MADE: 13-SEP-22
Guilin CN 541805 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Solea
Convergent Dental, Inc. 510(k) NO: K221761(Traditional)
ATTN: Jhung Vojir PHONE NO : 215 2052219
140 Kendrick Street SE DECISION MADE: 14-SEP-22
Needham MA 02494 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BRAVOS Afterloader Family: BRAVOS Afterloader System, Transfer Guide Tubes and Length Assessment Device
Varian Medical Systems Inc. 510(k) NO: K221797(Traditional)
ATTN: Peter J. Coronado PHONE NO : 650 4246320
3100 Hansen Way, M/S/E-110 SE DECISION MADE: 14-SEP-22
Palo Alto CA 94304 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Electric Wheelchair, Model: 9000N
Silver Fox Corporation Limited 510(k) NO: K221799(Traditional)
ATTN: Chen Yan PHONE NO : 86 13422 526650
No. 18, 1st TongLe Road, TongLe InSE DECISION MADE: 16-SEP-22
Guangdong CN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DePuy Synthes 3.5mm Intrapelvic Acetabular System
DePuy Synthes 510(k) NO: K221809(Traditional)
ATTN: Alyssa Bryan PHONE NO : 360 6724105
1301 Goshen Parkway SE DECISION MADE: 20-SEP-22
West Chester PA 19380 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 35g Standard SMMS Surgical Gown; 35g Reinforced SMMS Surgical Gown;43g Standard SMMS Surgical Gown;43g Reinforced SMMS Surgical Gown ;50g Standard SMMS Surgical Gown; 50g Reinforced SMMS Surgical Gown;BVB Surgical Gown
Winner Medical Co., Ltd. 510(k) NO: K221819(Traditional)
ATTN: Mingni Liu PHONE NO : 86 755 28138888
Winner Industrial Park, No.660 BulSE DECISION MADE: 19-SEP-22
Guangdong CN 515109 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ATEC IOM Accessory Instruments
Alphatec Spine, Inc. 510(k) NO: K221821(Traditional)
ATTN: Sandy Gill PHONE NO : 1 760 4946633
1950 Camino Vido Roble SE DECISION MADE: 23-SEP-22
Carlsbad CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Wet Flavored Personal Lubricants
Trigg Laboratories, Inc. 510(k) NO: K221829(Traditional)
ATTN: Marla Bolden PHONE NO : 702 9574400
4220 W. Windmill Ln. Suite 140 SE DECISION MADE: 23-SEP-22
Las Vegas NV 89139 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Lancet
Hebei Xinle Sci&Tech Co., Ltd 510(k) NO: K221839(Traditional)
ATTN: Jianxun Tian PHONE NO : 86 311 88581058
No.2, Xingye Street, Xinle City SE DECISION MADE: 19-SEP-22
Shijiazhuang CN 050700 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GEM Biover Microvascular Clamps
Synovis Micro Companies Alliance, 510(k) NO: K221843(Special)
ATTN: Julie Carlston PHONE NO : 651 7967511
(a subsidiary of Baxter InternatioSE DECISION MADE: 14-SEP-22
Birmingham AL 35211 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nitrile Examination Glove, Pink Color; Nitrile Examination Glove, Black Color, Nitrile Examination Glove, White Color
Guangdong Kingfa Sci. & Tech. Co.,510(k) NO: K221887(Traditional)
ATTN: Xiaoge Yu PHONE NO : 86 135 70952157
No. 28 Delong Ave., Shijiao Town, SE DECISION MADE: 24-SEP-22
Qingyuan CN 511545 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TROJAN Fire & Ice lubricated male natural rubber latex condom
Church & Dwight Co., Inc. 510(k) NO: K221906(Traditional)
ATTN: Supreet Sahota-Bhatti PHONE NO : 609 8067893
500 Charles Ewing Blvd. SE DECISION MADE: 28-SEP-22
Ewing NJ 08628 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: JO CUMPLAY Personal Lubricant
CC Wellness LLC 510(k) NO: K221908(Traditional)
ATTN: Marlent Perez PHONE NO : 661 2951700
29000 N. Hancock Pkwy. SE DECISION MADE: 20-SEP-22
Valencia CA 91355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ReFlow System Mini
Anuncia Medical, Inc. 510(k) NO: K221918(Traditional)
ATTN: Elsa Chi Abruzzo PHONE NO : 513 5006736
1355 N Scottsdale Rd, Suite 370 SE DECISION MADE: 29-SEP-22
Scottsdale AZ 85257 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Smith+Nephew INTELLIO Tablet
Smith+Nephew 510(k) NO: K221929(Traditional)
ATTN: Kathleen Solomon PHONE NO :
150 Minuteman Road SE DECISION MADE: 06-SEP-22
Andover MA 01810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Omni Legend
GE Healthcare 510(k) NO: K221932(Traditional)
ATTN: Alexandra Lifshits PHONE NO : 972 4 8563666
4 Hayozma Street SE DECISION MADE: 02-SEP-22
Tirat Hacarmel IL 30200 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Savewo ClassicMASK
Savewo Limited 510(k) NO: K221957(Traditional)
ATTN: Melanie Choi PHONE NO : 852 5503 2370
1/F & 2/F, 266-270 Texaco Road, TsSE DECISION MADE: 02-SEP-22
Hong Kong CN 0000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Dynamic TiBase
Talladium Espana, SL 510(k) NO: K221966(Traditional)
ATTN: Xavier Soca Filella PHONE NO : 34 973 289580
Virginia Woolf, 17 SE DECISION MADE: 15-SEP-22
Lleida ES 25005 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: StageOne™ Shoulder Cement Spacer Molds
Biomet, Inc. 510(k) NO: K221968(Traditional)
ATTN: Neha Sreenath PHONE NO : 0065 85041704
56 East Bell Drive, P.O. Box 587 SE DECISION MADE: 15-SEP-22
Warsaw IN 46581 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Surgical Face Mask (Non-sterile)
Xiantao Junhui Plastic Products Co510(k) NO: K221976(Traditional)
ATTN: Fiona Tian PHONE NO : 86 15027 285720
No. 3, Babu Industrial Park, PengcSE DECISION MADE: 20-SEP-22
Xiantao CN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Erchonia GVL
Erchonia Corporation 510(k) NO: K221987(Traditional)
ATTN: Travis Sammons PHONE NO : 888 2420571
650 Atlantis Road SE DECISION MADE: 01-SEP-22
Melbourne FL 32904 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: S.I.N. Instrument Kits
S.I.N. - Sistema De Implante Nacio510(k) NO: K222005(Traditional)
ATTN: Denise Domiciano PHONE NO : 55 11 21693000 3236
Avenida Vereador Abel Ferreira, 11SE DECISION MADE: 29-SEP-22
Sao Paulo BR 03340-000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HD-550 Video Endoscope System
Sonoscape Medical Corp. 510(k) NO: K222020(Traditional)
ATTN: Toki Wu PHONE NO : 86 755 26722890
Room 201 & 202, 12th Building, SheSE DECISION MADE: 08-SEP-22
Shenzhen CN 51857 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RightLance Blood Lancing System
Beijing Ruicheng Medical Supplies 510(k) NO: K222034(Traditional)
ATTN: Yuechao Li PHONE NO : 86 189 10106615
No.13 Yanqi Ave, Yanqi Economic DeSE DECISION MADE: 07-SEP-22
Beijing CN 101400 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Unscented Menstrual Tampon
Suzhou Borage Medical Technology C510(k) NO: K222046(Traditional)
ATTN: Zhou Nana PHONE NO : 86 512 66280008
No.9, Shiheshan Road, Dongshan TowSE DECISION MADE: 30-SEP-22
Suzhou CN 215107 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Spectrum IQ Infusion System with Dose IQ Safety Software
Baxter Healthcare Corporation 510(k) NO: K222048(Traditional)
ATTN: Jennifer Hoogheem PHONE NO : 224 2702693
25212 W. Illinois Route 120 SE DECISION MADE: 06-SEP-22
Round Lake IL 60073 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SpeediCath Flex Set
Coloplast 510(k) NO: K222059(Traditional)
ATTN: Preeti Jain PHONE NO : 1 612 4135614
1601 west river road north SE DECISION MADE: 21-SEP-22
MINNEAPOLIS MN 55411 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ez3D-i/E3
Ewoosoft Co., Ltd 510(k) NO: K222069(Traditional)
ATTN: Young Seok Kim PHONE NO : 82 31 80156172
801-ho, Vatechnetworks Bldg., 13, SE DECISION MADE: 06-SEP-22
Hwaseong-si KR 18449 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CellFX System
Pulse Biosciences, Inc. 510(k) NO: K222075(Traditional)
ATTN: Punam Gollamudi PHONE NO : 415 3054404
3957 Point Eden Way SE DECISION MADE: 02-SEP-22
Hayward CA 94545 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EFAI ChestSuite XR Pleural Effusion Assessment System
Ever Fortune.AI Co., Ltd. 510(k) NO: K222076(Traditional)
ATTN: Joseph Chang PHONE NO : 866 4 23226363
RM. D, 8 F., NO. 573, SEC. 2, TAIWSE DECISION MADE: 08-SEP-22
Taichung City TW 403020 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Arthrex SoftStitch
Arthrex, Inc 510(k) NO: K222078(Traditional)
ATTN: Kelsey Roberts PHONE NO : 1 239 6435553 72257
1370 Creekside Boulevard SE DECISION MADE: 14-SEP-22
Naples FL 34108-1945 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Safety Lancet
Ningbo Medsun Medical Co., Ltd. 510(k) NO: K222090(Traditional)
ATTN: Liu Ping PHONE NO : 86 574 86301708
No.55 Jinxi Road, Zhenhai SE DECISION MADE: 30-SEP-22
Ningbo CN 315221 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Grappler Suture Anchor System
Paragon 28, Inc. 510(k) NO: K222091(Traditional)
ATTN: Haylie Hertz PHONE NO : 303 7200017
14445 Grasslands Dr. SE DECISION MADE: 14-SEP-22
Englewood CO 80112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: V-PRO maX 2 Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System
STERIS 510(k) NO: K222093(Special)
ATTN: Anthony Piotrkowski PHONE NO : 440 3927437
5960 Heisley Rd SE DECISION MADE: 09-SEP-22
Mentor OH 44024 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Mariner RDX System
SeaSpine Orthopedics Corporation 510(k) NO: K222110(Traditional)
ATTN: Jesse Albright PHONE NO : 760 2165176
5770 Armada Drive SE DECISION MADE: 07-SEP-22
Carlsbad CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Unistik Touch Single-Use Safety Lancets - 16G, 21G, 23G, 28G and 30G
Owen Mumford Ltd 510(k) NO: K222111(Traditional)
ATTN: Darren Mansell PHONE NO : 44 0 1993812021
Brook Hill SE DECISION MADE: 07-SEP-22
Woodstock GB OX20 1TU 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: C630G LCD monitor, JUSHA-C630G LCD monitor, C630 LCD monitor, JUSHA-C630 LCD monitor
Nanjing Jusha Display Technology C510(k) NO: K222121(Traditional)
ATTN: Donny Lee PHONE NO : 86 025 83305050
8A, Block 1, 301 Hanzhongmen StreeSE DECISION MADE: 19-SEP-22
Nanjing CN 210036 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NB 1 SA Implant System
Arum Dentistry Co., Ltd. 510(k) NO: K222131(Special)
ATTN: Bo-Yeon Lim PHONE NO : 82 42 9353644
23, Gukjegwahak 11-ro, Yuseong-gu SE DECISION MADE: 19-SEP-22
Daejeon KR 34002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 3M™ Attest™ Hydrogen Peroxide Indicator Tape 1228
3M Company 510(k) NO: K222152(Traditional)
ATTN: Yumi Wackerfuss PHONE NO : 651 7373556
2510 Conway Avenue, Bldg. 275-5W-0SE DECISION MADE: 23-SEP-22
St. Paul MN 55144-1000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Single Use O-ring gasket syringe with ENFit Connector, Reusable O-ring gasket syringe with ENFit connector
Jiangsu Caina Medical Co., Ltd. 510(k) NO: K222155(Traditional)
ATTN: Jianwei Pan PHONE NO : 86 510 86205183
No. 23, Huanxi Rd. Zhutang Town SE DECISION MADE: 16-SEP-22
Jiangyin CN 214415 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Medical Surgical Mask
Guangzhou ZhengKang Medical Equipm510(k) NO: K222204(Traditional)
ATTN: Mike Wu PHONE NO : 86 136 00073056
Room101, No.9 Nanling Zhongxin KuaSE DECISION MADE: 23-SEP-22
GuangZhou CN 510540 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Air Compression Leg Massager (Models: S9036C, S9036B and S9036A)
Shenzhen Dongjilian Medical Tech C510(k) NO: K222206(Traditional)
ATTN: Zhang Hong PHONE NO : 86 755 89964118
B1/15F, Tonglu Industrial Area, ToSE DECISION MADE: 30-SEP-22
Shenzhen CN 518116 510(k) STATEMENT
DEVICE: SurgiLance® Safety Lancet
MediPurpose Pte. Ltd. 510(k) NO: K222224(Traditional)
ATTN: Adeline Yi PHONE NO : 65 6570 1965
10 Anson Road, No. 12-08 InternatiSE DECISION MADE: 22-SEP-22
Singapore SG 079903 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Arthrex 3.5 mm Locking Compression Plates
Arthrex Inc. 510(k) NO: K222244(Traditional)
ATTN: Stacy Valdez PHONE NO : 1_____ 239 6435553 72010
1370 Creekside Boulevard SE DECISION MADE: 30-SEP-22
Naples FL 34108-1945 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GlasIonomer FX ULTRA
Shofu Dental Corporation 510(k) NO: K222253(Traditional)
ATTN: Mauro Malzyner PHONE NO : 760 7363277 202
1225 Stone Drive SE DECISION MADE: 22-SEP-22
San Marcos CA 92078 510(k) STATEMENT
DEVICE: Diosculpt
Shanghai Wonderful Opto-Electrics 510(k) NO: K222265(Traditional)
ATTN: Lily Zhou PHONE NO : 0086 21 62642623
2F, Building 11, Lane 1175, TongpuSE DECISION MADE: 23-SEP-22
Shanghai CN 200333 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Surgical Mask (GFM 96, GFM 91, GFM 90, GFM 88, GFM 81, GFM 80)
Jingzhou Haixin Green Cross Medica510(k) NO: K222266(Traditional)
ATTN: Lei Da PHONE NO : 86 27 82836722
Yongxing North Road No.2 Jingzhou SE DECISION MADE: 26-SEP-22
Jingzhou CN 434007 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ArcSP Suprapubic Sling System
UroCure LLC 510(k) NO: K222293(Special)
ATTN: John Nelson PHONE NO : 612 8506814
701 North 3rd Street, Suite 110 SE DECISION MADE: 21-SEP-22
Minneapolis MN 55401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Black Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested for Use With Chemotherapy Drugs, the Opioid Fentanyl Citrate, simulated Gastric Acid, and Fentanyl In Gastric Acid
Onetexx SDN BHD 510(k) NO: K222294(Traditional)
ATTN: Freddy Low PHONE NO : 605 8070666
No 73-86, JLN Logam 5, PerindustriSE DECISION MADE: 24-SEP-22
Kamunting MY 34600 510(k) STATEMENT
DEVICE: IPL Hair Removal Device
Shenzhen Goodwind Technology Devel510(k) NO: K222316(Traditional)
ATTN: Ziming Yang PHONE NO : 86 138 02283843
4th&5Th Floor,2nd Part Of BuildingSE DECISION MADE: 28-SEP-22
Shenzhen CN 518116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SteriCUBE® Multiple Tray Sterilization Systems
SteriCUBE, LLC 510(k) NO: K222328(Traditional)
ATTN: Michele Mauzerall PHONE NO : 908 3007093
2701 Beach Boulevard South SE DECISION MADE: 28-SEP-22
Gulfport FL 33707 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BriefCase
Aidoc Medical, Ltd. 510(k) NO: K222329(Traditional)
ATTN: Amalia Schreie PHONE NO : 972 73 7946870
3 Aminadav St., SE DECISION MADE: 28-SEP-22
Tel Aviv IL 6706703 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WatchPAT300 (WP300)
Itamar Medical, Ltd 510(k) NO: K222331(Special)
ATTN: Efrat Litman PHONE NO : 972 4 6177000
9 Halamish Street SE DECISION MADE: 14-SEP-22
Casearea IL 3088900 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: uDR 380i Pro
Shanghai United Imaging Healthcare510(k) NO: K222339(Traditional)
ATTN: Xin Gao PHONE NO : 86 216707 68885386
No. 2258 Chengbei Rd., Jiading IndSE DECISION MADE: 30-SEP-22
Shanghai CN 201807 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Betel Gloves Nitrile Examination Glove Powder Free
Betel care Sdn. Bhd. 510(k) NO: K222342(Traditional)
ATTN: Abdul Rahman Richard AbdullaPHONE NO : 603 3290 33301
Lot 3342, Jalan Keretapi Lama SE DECISION MADE: 24-SEP-22
7 ½ Miles, Off Jalan Kapar MY 422510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GM85
Samsung Electronics Co., LTD. 510(k) NO: K222353(Traditional)
ATTN: Jaesang Noh PHONE NO : 82 2 21932444
129, Samsung-Ro, Yeongtong-Gu SE DECISION MADE: 29-SEP-22
Suwon-Si KR 16677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Anteralign™ LS Spinal System with Titan nanoLOCK™ Surface Technology MAZORX Stealth(TM) Edition
Medtronic Sofamor Danek USa, Inc. 510(k) NO: K222383(Special)
ATTN: Elizabeth Hamilton PHONE NO : 901 8318017
1800 Pyramid Place SE DECISION MADE: 29-SEP-22
Memphis TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CAPTIVATE® Compression Screws
Globus Medical, Inc. 510(k) NO: K222409(Special)
ATTN: Jennifer Antonacci PHONE NO : 610 9301800 1861
Valley Forge Business Center 2560 SE DECISION MADE: 08-SEP-22
Audubon PA 19403 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ellusa Reusable Neutral Plates
Ellusa, LLC 510(k) NO: K222425(Special)
ATTN: Suzanne Lucas PHONE NO : 516___ 6341370
2473 Grand Avenue SE DECISION MADE: 08-SEP-22
Baldwin NY 11510 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Perfetta Moderate Medical Face Mask
Phu Bao Group Company Limited 510(k) NO: K222426(Third Party - Traditional)
ATTN: Le Pham Minh Ngoc PHONE NO : 84 28 39142980
5 floor, CJ Building, 02Bis-4-6 LeSE DECISION MADE: 02-SEP-22
Ho Chi Minh VN 70000 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: Ellusa Reusable Bipolar Cable
Ellusa, LLC 510(k) NO: K222429(Special)
ATTN: Suzanne Lucas PHONE NO : 516 6341370
2473 Grand Avenue SE DECISION MADE: 09-SEP-22
Baldwin NY 11510 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vis-U-All Low Temperature Sterilization Pouches/Tubing, PRO-LITE Sterilization Trays
Steris 510(k) NO: K222440(Special)
ATTN: Anthony Piotrkowski PHONE NO : 440 3927437
5960 Heisey Road SE DECISION MADE: 09-SEP-22
Mentor OH 44060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DISPOSABLE VINYL EXAMINATION GLOVES (Pink, Black, Blue)
Anhui Bytech Medical Supplies Co.,510(k) NO: K222442(Traditional)
ATTN: Lijun Chen PHONE NO : 86 510 85093588
LingBi Economic Development Zone(NSE DECISION MADE: 28-SEP-22
SuZhou City CN 234200 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ArcTO Transobturator Sling System
UroCure LLC 510(k) NO: K222468(Special)
ATTN: John Nealon PHONE NO : 612 8506814
701 North 3rd Street, Suite 110 SE DECISION MADE: 15-SEP-22
Minneapolis MN 55401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AGILON XO Shoulder System
implantcast, GmbH 510(k) NO: K222482(Traditional)
ATTN: Ms. Juliane Hoppner PHONE NO : 49 4161 7440
Luneburger Schanze 26 SE DECISION MADE: 28-SEP-22
Buxtehude DE 21615 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AIR OPTIX COLORS
Alcon Laboratories, Inc. 510(k) NO: K222500(Special)
ATTN: Sherri Lakota PHONE NO : 1 817 6155472
6201 South Freeway SE DECISION MADE: 15-SEP-22
Fort Worth TX 76134-2099 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Resolution Clip, Resolution 360 Clip, Resolution 360 ULTRA Clip
Boston Scientific Corporation 510(k) NO: K222503(Special)
ATTN: Jia Huang PHONE NO : 617 9820126
100 Boston Scientific Way SE DECISION MADE: 14-SEP-22
Marlborough MA 01752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Integrity-SI Fusion System
OsteoCentric Technologies 510(k) NO: K222512(Special)
ATTN: Todd Evans PHONE NO : 435___ 7572253___
75 West 300 North Suite 150 SE DECISION MADE: 12-SEP-22
Logan UT 84321 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ClearPoint System
ClearPoint Neuro, Inc. 510(k) NO: K222519(Special)
ATTN: Mary McNamara-Cullinane PHONE NO : 949 9006833
5 Musick SE DECISION MADE: 16-SEP-22
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MCB UNIT Model: V10GMCBUS
Lamidey Noury Medical 510(k) NO: K222542(Third Party - Traditional)
ATTN: M. Guillaume Noury PHONE NO : 33 1692 06969
3 rue des petits ruisseaux SE DECISION MADE: 21-SEP-22
Verriere Le Buisson FR 91370 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: reepot Nd; YAG laser system
Ilooda Co., Ltd. 510(k) NO: K222555(Traditional)
ATTN: Yunjung HA PHONE NO : 82 31 2784660
9F, 25, Deokcheon-Ro 152beon-Gil, SE DECISION MADE: 23-SEP-22
Anyang-Si KR 14084 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Align
Acuity Surgical Devices, LLC 510(k) NO: K222561(Special)
ATTN: Bryan Cowan PHONE NO : 1 844 2284890
8710 N Royal Lane SE DECISION MADE: 23-SEP-22
Irving TX 75063 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OptiCross™ 18 Peripheral Imaging Catheter
Boston Scientific Corporation 510(k) NO: K222568(Special)
ATTN: Cassie Clark PHONE NO : 763 4941425
1 Scimed Place SE DECISION MADE: 23-SEP-22
Maple Grove MN 55311 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Pusen Single Use Flexible Video Cystoscope System (Single Use Flexible Video Cystoscope: PC200-AS, PC200-AR, PC200-S and PC200-R; HD Medical Video Endoscope Image Processor: PV300)
Zhuhai Pusen Medical Technology Co510(k) NO: K222602(Traditional)
ATTN: Changshen Wang PHONE NO : 086 7566 880865
5/F, Building 1, No 33, Ke Ji San SE DECISION MADE: 26-SEP-22
Zhuhai CN 519085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: iFuse TORQ® Implant System
SI-BONE, Inc. 510(k) NO: K222605(Special)
ATTN: Meirav Harsat PHONE NO : 650 8624942
471 El Camino Real Suite 101 SE DECISION MADE: 29-SEP-22
Santa Clara CA 95050 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900, S40 Sterilant Concentrate
STERIS Corporation 510(k) NO: K222615(Special)
ATTN: Jennifer Nalepka PHONE NO : 440 3927458
5960 Heisley Road SE DECISION MADE: 28-SEP-22
Mentor OH 44060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Shield System
Radiaction Ltd. 510(k) NO: K222625(Special)
ATTN: Jonathan Yifat PHONE NO : 972 54 7257565
10 Hanechoshet St. SE DECISION MADE: 30-SEP-22
Tel Aviv IL 6971072 510(k) STATEMENT
DEVICE: EndoGI S-Path Biliary Stent System
EndoGI Medical 510(k) NO: K222627(Special)
ATTN: Omri Naveh PHONE NO : 972 52 4625474
13 Wadi El Hadj SE DECISION MADE: 28-SEP-22
Nazareth IL 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Resonic Rapid Acoustic Pulse Device
Zeltiq Aesthetics, Inc. 510(k) NO: K222629(Traditional)
ATTN: Saurabh Jamkhindikar PHONE NO : 1 925 2416299
(acquired Soliton, Inc. through paSE DECISION MADE: 25-SEP-22
Pleasanton CA 94588 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Nitrile Examination Glove(Tested for use with Chemotherapy Drug)
Inner Mongolia Cureguard Medical T510(k) NO: K222642(Traditional)
ATTN: Guo Hua PHONE NO : 86 134 85097856
Room 326, Management Committee of SE DECISION MADE: 20-SEP-22
Baotou CN 014100 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INT Introducer Set
Shanghai Kindly Medical Instrument510(k) NO: K222647(Third Party - Traditional)
ATTN: Xu Jianhai PHONE NO : 086 21 59140056 8870
No.925, Jinyuan yi Road SE DECISION MADE: 13-SEP-22
Shanghai CN 201803 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: 5000 Compact Series Ultrasound Systems (Ultrasound System 5500 G, Ultrasound System 5500 P, Ultrasound System 5500 W, Ultrasound System 5500 CV, Ultrasound System 5300 G, Ultrasound System 5300 P, Ultrasound System 5300 W)
Philips Ultrasound LLC 510(k) NO: K222648(Third Party - Traditional)
ATTN: Shilpa Rapaka PHONE NO : 203 2136862 ______
22100 Bothell Everett Hwy SE DECISION MADE: 27-SEP-22
Bothell WA 98021 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: OtoSight Middle Ear Scope
PhotoniCare, Inc 510(k) NO: K222655(Special)
ATTN: Ryan Shelton PHONE NO : 866 4113277
1902 Fox Drive, Suite F SE DECISION MADE: 26-SEP-22
Champaign IL 61820 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Digital Radiography CXDI-CS01
Canon Inc. 510(k) NO: K222661(Special)
ATTN: Akira Hirai PHONE NO : 81 3 37582111
9-1 Imaikami-cho, Nakahara-ku SE DECISION MADE: 27-SEP-22
Kawasaki JP 211-8501 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Digital Radiography CXDI-Elite, Digital Radiography E1
Canon Inc. 510(k) NO: K222687(Special)
ATTN: Mr. Akira Hirai PHONE NO : 81 3 37582111
9-1 Imaikami-cho, Nakahara-ku SE DECISION MADE: 29-SEP-22
Kawasaki JP 211-8501 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Single-use medical latex examination gloves (LG100)
Fitone Latex Products Co., Ltd. Gu510(k) NO: K222693(Traditional)
ATTN: Christine Ou PHONE NO : 0759 790 5808
No.5 Huitong road, Lingbei IndustrSE DECISION MADE: 24-SEP-22
Zhanjiang CN 524338 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AMBARINO High-Class
Creamed GmbH & Co. Produktions- un510(k) NO: K222723(Third Party - Traditional)
ATTN: Robert Lemmer PHONE NO : 490 6421 1689930
Tom-Mutters-Str. 4a SE DECISION MADE: 09-SEP-22
Marburg DE 35041 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: LightForce Orthodontic System
LightForce Orthodontics 510(k) NO: K222764(Third Party - Special)
ATTN: Kelsey Fafara PHONE NO : 800 4810185 701___
44 Third Ave SE DECISION MADE: 14-SEP-22
Burlington MA 01803 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: Irrisept Antimicrobial Wound Lavage
Irrimax Corporation 510(k) NO: K222804(Special)
ATTN: Tanya Eberle PHONE NO : 404 6259593
1665 Lakes Parkway, Suite 102 SE DECISION MADE: 22-SEP-22
Lawrenceville GA 30043 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AMSCO 600 Steam Sterilizer, V-PRO maX 2 Low Temperature Sterilization System, V-PRO s2 Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization System, RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP and 7053HP Single Chamber Washer Disinfector
Steris 510(k) NO: K222849(Special)
ATTN: Anthony Piotrkowski PHONE NO : 440 3927437
5960 Heisley Rd SE DECISION MADE: 30-SEP-22
Mentor OH 44060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FREEPRINT crown
DETAX GmbH 510(k) NO: K222877(Third Party - Traditional)
ATTN: Markus Stratmann PHONE NO : 49 7243 510138
Carl-Zeiss-Strasse 4 SE DECISION MADE: 23-SEP-22
Ettlingen DE D-76275 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
TOTAL 510(k)s THIS PERIOD 280
TOTAL WITH SUMMARIES 264
TOTAL WITH STATEMENTS 16
