510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD August 2022
DEVICE: Solidence Multipockets
Solidence Surgical Corporation 510(k) NO: K191131(Traditional)
ATTN: Morris Azad PHONE NO : 1 818 3616900
1104 San Fernando Road SE DECISION MADE: 03-AUG-22
San Fernando CA 91340 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Powered Inflatable Tube Massager - SLIM UP DRAIN
Foggiare Technologies LLC 510(k) NO: K201730(Traditional)
ATTN: Thierry Germanovitch PHONE NO : 954 9998063
1920 West Bay Drive, Suite 4 SE DECISION MADE: 22-AUG-22
Largo FL 33770 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ThermaCor 1200 Disposable Sets for the ThermaCor 1200 Rapid Thermal Infusion System
Smisson-Cartledge Biomedical LLC 510(k) NO: K202461(Traditional)
ATTN: Calder Clay III PHONE NO : 478 7449992
487 Cherry Street - Third Street TSE DECISION MADE: 12-AUG-22
Macon GA 31201 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Hemo-Lyte C Cartridge
Di-Chem, Inc. 510(k) NO: K202508(Traditional)
ATTN: Keith Buchholz PHONE NO : 763 4228311
12297 Ensigh Avenue North SE DECISION MADE: 12-AUG-22
Champlin MN 55316 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Bioland G-425-2V Blood Glucose Monitoring System, Bioland G-425-2 Blood Glucose Monitoring System
Bioland Technology Ltd. 510(k) NO: K202739(Special)
ATTN: Yiqing Feng PHONE NO : 86 755 36900999
No. A6B7 (Block G), ShangRong InduSE DECISION MADE: 12-AUG-22
Shenzhen CN 518116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CAREWE Surgical Face Mask Models N001-AW, N002-AW, and N003-AW
HuiZhou TianChang Industrial Co., 510(k) NO: K203078(Abbreviated)
ATTN: Johnny Chan PHONE NO : 86 752 3183968
No.2 XingDe East Road, DongJiang HSE DECISION MADE: 19-AUG-22
Huizhou CN 516005 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QOCA Portable ECG Monitoring Device
Quanta Computer Inc. 510(k) NO: K210179(Traditional)
ATTN: Vivian Yang PHONE NO : 886 3 3272345 12928
No. 188, Wenhua 2nd Road, Guishan SE DECISION MADE: 02-AUG-22
Taoyuan City TW 33377 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: implaFit® hip stems
implantcast, GmbH 510(k) NO: K210678(Traditional)
ATTN: Juliane Hoppner PHONE NO : 49 4161 7440
Luneburger Schanze 26 SE DECISION MADE: 17-AUG-22
21614 Buxtehude DE 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Bio-MEM Ti Reinforced Membrane
B&Medi Co., Ltd. 510(k) NO: K210797(Traditional)
ATTN: Taesu Kwon PHONE NO : 82 2 62950085
56-33, Chukhang-daero 296Beon-gil,SE DECISION MADE: 18-AUG-22
Incheon KR 22339 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix)
I.T.S. GmbH 510(k) NO: K210935(Traditional)
ATTN: Florian Grill PHONE NO : 0043 316 2112140
Autal 28 SE DECISION MADE: 31-AUG-22
Lassnitzhoehe AT 8301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Foundation Dermal Regeneration Scaffold (DRS) Solo
Bionova Medical Inc. 510(k) NO: K210949(Traditional)
ATTN: Alex Greene PHONE NO : 901 7482581
3012 Centre Oak Way, Ste 102 SE DECISION MADE: 11-AUG-22
Germantown TN 38138 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Dose IQ Safety Software
Baxter Healthcare Corporation 510(k) NO: K211124(Traditional)
ATTN: Michelle Rixie PHONE NO : 224 2702861
One Baxter Parkway SE DECISION MADE: 30-AUG-22
Deerfield IL 60015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Novum IQ Syringe Pump
Baxter Healthcare Corporation 510(k) NO: K211125(Traditional)
ATTN: Dhiraj Bizzul PHONE NO : 847 9096828
One Baxter Parkway SE DECISION MADE: 30-AUG-22
Deerfield IL 60015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WiEMSpro
Medical Cables S.L. 510(k) NO: K211298(Traditional)
ATTN: José Fuertes Peña PHONE NO : 34 95 2218991
Calle Ferrocarril del Puerto 18 - SE DECISION MADE: 25-AUG-22
Málaga ES 29002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Powder Free Latex Examination Glove, Non-Sterile
WRP Asia Pacific SDN. BHD. 510(k) NO: K211601(Traditional)
ATTN: Siti Syamimie Atirah Binti MPHONE NO : 60 3 87061486
Lot 1, Jalan 3, Kawasan PerusahaanSE DECISION MADE: 22-AUG-22
Sepang MY 43900 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CenterMed Patient Matched Assisted Surgical Planning (ASP) System
CenterMed, Inc. 510(k) NO: K211614(Traditional)
ATTN: Jash Bhayani PHONE NO : 855 8408823
226 N Wiget Ln SE DECISION MADE: 04-AUG-22
Walnut Creek CA 94598 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Dasky Disposable Sampling Tube (Model name: VSM02)
Ningbo Dasky Life Science Co., Ltd510(k) NO: K211675(Traditional)
ATTN: Wilson Wong PHONE NO : 86 135 66546046
No. 6, Donggong 1st Road, Yinzhou SE DECISION MADE: 08-AUG-22
Ningbo CN 315000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: The GOOD High Fluid-Resistant Surgical Mask, The GOOD High Fluid-Resistant Surgical Procedure KF Mask, The GOOD Super Guard Design High Fluid-Resistant Surgical Mask, The KOEASY High Fluid-Resistant Surgical Mask, The KOEASY High Fluid-Resistant Surgical Procedure KF Mask, The KOEASY Super Guard Design High Fluid-Resistant Surgical Mask
The GOOD Corporation 510(k) NO: K211771(Traditional)
ATTN: Hak Rae Lee PHONE NO : 82 31 6849812
47-13 Eoso 3-gil, Cheongbuk-eup SE DECISION MADE: 24-AUG-22
Pyeongtaek-si CN 17795 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MRI Planner
Spectronic Medical AB 510(k) NO: K211841(Traditional)
ATTN: Per Bruhn PHONE NO : 46 735 116042
Karbingatan 36 SE DECISION MADE: 25-AUG-22
Helsingborg SE 25467 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Sterile Syringe, with/without needle;luer/luer-lock, Disposable insulin syringe, Disposable Hypodermic needle
Shandong Zhushi Pharmaceutical Gro510(k) NO: K212033(Traditional)
ATTN: Junhui Zhu PHONE NO : 86 157 64021131
No. 6, Shande Road, Shan County SE DECISION MADE: 17-AUG-22
Heze CN 274300 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SurGuard3 Safety Hypodermic Needle
Terumo Europe N.V. 510(k) NO: K212095(Traditional)
ATTN: L. Decoster PHONE NO : 32 1638 1365
Interleuvenlaan 40 SE DECISION MADE: 22-AUG-22
Leuven BE 3001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GlucoSure Link Blood Glucose Monitoring System
Apex Biotechnology Corp. 510(k) NO: K212140(Traditional)
ATTN: Lisa Liu PHONE NO : 886 3 5641952
No. 7, Li-Hsin Rd. V, Hsinchu ScieSE DECISION MADE: 25-AUG-22
Hsinchu TW 30078 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ImmunoCAP Allergen f433, Allergen component rTri a 14 LTP, Wheat, ImmunoCAP Allergen f416, Allergen component rTri a 19 Omega-5 Gliadin, Wheat, ImmunoCAP Allergen f449, Allergen component rSes i 1 Sesame seed
Phadia AB 510(k) NO: K212181(Traditional)
ATTN: Anna Torell Holm PHONE NO : 46 18 163875
Rapsgatan 7P SE DECISION MADE: 03-AUG-22
Uppsala SE 75137 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITEK 2 AST- Gram Positive Telavancin (<=0.015 - >=1 µg/mL)
bioMerieux, Inc 510(k) NO: K212243(Traditional)
ATTN: Cherece L. Jones PHONE NO : 314 7318684
595 Anglum Rd. SE DECISION MADE: 08-AUG-22
Hazelwood MO 63042 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GlucoLeader Enhance 2 Blood Glucose Monitoring System
HMD BioMedical Inc. 510(k) NO: K212248(Special)
ATTN: Chin-Hsiung Hsu PHONE NO : 886 3 5895000
No. 181, Minsheng Street SE DECISION MADE: 29-AUG-22
Hsinchu County TW 30548 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Apollo Duet (Model : APD-4000)
Weero Co. 510(k) NO: K212253(Traditional)
ATTN: Jimin Han PHONE NO : 82 31 51828588
A605 Venture Valley II, 142-10, SaSE DECISION MADE: 25-AUG-22
Suwon-si KR 16648 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cross Protection ResQ300 Plus Surgical Face Mask
Cross Protection (M) Sdn Bhd 510(k) NO: K212273(Traditional)
ATTN: Grace Tan PHONE NO : 60 3 33920000
11, JLN Perindustrian5, JLN Meru SE DECISION MADE: 17-AUG-22
Klang MY 41050 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Novo
PathAI, INC. 510(k) NO: K212361(Traditional)
ATTN: Kathy Wack PHONE NO : 617 5008457
1325 Boylston Avenue SE DECISION MADE: 11-AUG-22
Boston MA 02215 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BLT Dental Implant System
Bio Concept Co., Ltd 510(k) NO: K212364(Traditional)
ATTN: Tianshui Li PHONE NO : 86 519851 72266
Unit C, No. 26, Huashan Middle RoaSE DECISION MADE: 10-AUG-22
Changzhou CN 213022 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Leaderflex Mini and Leaderflex Nano
Vygon USA 510(k) NO: K212370(Traditional)
ATTN: Lauren Doyle PHONE NO : 774 3641125
2750 Morris Rd Suite A200 SE DECISION MADE: 29-AUG-22
Lansdale PA 19446 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: YUWELL Finger Pulse Oximeter
Jiangsu Yuyue Medical Equipment & 510(k) NO: K212385(Traditional)
ATTN: Yuzhuo Wang PHONE NO : 86 0511 86900827
Yunyang Industrial Park SE DECISION MADE: 16-AUG-22
Danyang CN 212300 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Non-sterile, Powder-Free Latex Examination Glove Ocean Blue, Violet Blue, Black and Natural White
Sri Trang Gloves (Thailand) Public510(k) NO: K212482(Abbreviated)
ATTN: Jarinya Jirokjul PHONE NO : 66 74 344677
10 SOi 10 Phetkasem Road SE DECISION MADE: 09-AUG-22
Hatyai TH 90110 510(k) STATEMENT
DEVICE: Jeesung Safety Syringe and Single Use Needles
JeeSung Medical Co., Ltd. 510(k) NO: K212518(Special)
ATTN: Choi Yong Hyun PHONE NO : 82 42 9326061
54, Mujini 1-gil, Daedeok-gu SE DECISION MADE: 18-AUG-22
Daejeon KR 34340 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Advcare Vial Direct to Bag (VDB) Needle-free Admixture Devices
Advcare Medical 510(k) NO: K212525(Traditional)
ATTN: Meng T. Tan PHONE NO : 626 2023457
No. 36, Sinsing Street, Shulin DisSE DECISION MADE: 19-AUG-22
New Taipei TW 23877 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Bonvadis Topical Cream
StemCyte Inc. 510(k) NO: K212554(Traditional)
ATTN: Angel Hsieh PHONE NO : 886 934 051402
13800 Live Oak Avenue SE DECISION MADE: 19-AUG-22
Baldwin Park CA 91706 510(k) STATEMENT
DEVICE: UniVit HE, UniVit UHS
VisionCare Devices, LLC. 510(k) NO: K212763(Traditional)
ATTN: Rick Morgan PHONE NO : 1 530 3642271
6100 Bellevue Lane SE DECISION MADE: 10-AUG-22
Anderson CA 96007 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TightRail Guardian Motorized Dilator Sheath
Spectranetics, Inc. 510(k) NO: K212784(Traditional)
ATTN: Jordan Baum PHONE NO : 719 2470183
9965 Federal Drive SE DECISION MADE: 24-AUG-22
Colorado Springs CO 80921 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: XLase Plus
Biotec Italia, SRL 510(k) NO: K212790(Traditional)
ATTN: Edoardo Milanello PHONE NO : 39 0444 591683
Viale della Repubblica 20, 36031 SE DECISION MADE: 15-AUG-22
Dueville (VI) IT 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MONOFIX PGCL, knotless wound closure device
Samyang Holdings Corp., Ltd. 510(k) NO: K212810(Traditional)
ATTN: Ahram Kim PHONE NO : 82 42 9303134
55, Munpyeongseo-ro, 18beon-gil SE DECISION MADE: 05-AUG-22
Daedeok-gu KR 34302 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sterile Hypodermic Syringe for Single Use, with/without Needle, Sterile Hypodermic Needle for Single Use
Jiangsu Jichun Medical Devices Co.510(k) NO: K212846(Traditional)
ATTN: Zhu Pingnan PHONE NO : 86 519 88906510
NO.98, Baiyang Bridge, Zhenglu ToSE DECISION MADE: 30-AUG-22
Changzhou CN 213111 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: iClean Viral Transport System (VTM-RT kit)
Huachenyang (Shenzhen) Technology 510(k) NO: K212856(Third Party - Traditional)
ATTN: Robin Chu PHONE NO : 86 133 92812025
F8/Bldg 4, Hengchangrong High InduSE DECISION MADE: 18-AUG-22
Shenzhen CN 518103 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: Sotair Device
Safe BVM Corporation 510(k) NO: K212905(Traditional)
ATTN: Haris Shekhani PHONE NO : 314 973 6606
1120 Weidman Road SE DECISION MADE: 18-AUG-22
Chesterfield MO 63017 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KDL Safety Needles
Shanghai Kindly Enterprise Develop510(k) NO: K212972(Traditional)
ATTN: Liu Huarong PHONE NO : 86 021 69118232
No. 658 Gaochao Road SE DECISION MADE: 18-AUG-22
Shanghai CN 201803 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Clear Aligner
Shenzhen Meiming Dentistry Technol510(k) NO: K213026(Traditional)
ATTN: Fei Hu PHONE NO : 86 132 19006323
Floor 3, Buliding D, Fuxinlin InduSE DECISION MADE: 16-AUG-22
Shenzhen CN 518102 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 2.1 x 255mm Drill, 22mm Stop
Biomet Micofixation 510(k) NO: K213072(Traditional)
ATTN: Mark Wladkowski PHONE NO : 904 3623940
1520 Tradeport Drive SE DECISION MADE: 23-AUG-22
Jacksonville FL 32218 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Auxilock Draw Tight Suture-Based Anchor
Auxein Medical Private Limited 510(k) NO: K213109(Traditional)
ATTN: Rahul Luthra PHONE NO : 91 971 7586969
Plot No. 168, 169, 170 Phase-IV, SSE DECISION MADE: 22-AUG-22
Sonipat IN 131028 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Benchmark BMX96 Access System
Penumbra, Inc. 510(k) NO: K213390(Traditional)
ATTN: Buu Buu Ly PHONE NO : 510 9902332
One Penumbra Place SE DECISION MADE: 18-AUG-22
Alameda CA 95132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HemosIL ReadiPlasTin
Instrumentation Laboratory Co. 510(k) NO: K213426(Traditional)
ATTN: Carol Marble PHONE NO : 781 8614467
180 Hartwell Road SE DECISION MADE: 16-AUG-22
Bedford MA 01730 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Root ZX3
J. Morita USA, Inc. 510(k) NO: K213477(Traditional)
ATTN: Fujio Zushi PHONE NO : 949 5819600
9 Mason SE DECISION MADE: 03-AUG-22
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vented Vial Adapter 20mm
West Pharma Services IL, Ltd. 510(k) NO: K213513(Traditional)
ATTN: llanit Goldgraber PHONE NO : 972 0 9777866
4 Hasheizaf St SE DECISION MADE: 31-AUG-22
Ra'anana IL 4366411 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AXIR-CX
Radisen Co., Ltd 510(k) NO: K213520(Traditional)
ATTN: John Lim PHONE NO : 82 31 80849762
B-602, Hifield Building, 66, BeolmSE DECISION MADE: 19-AUG-22
Anyang-si KR 14058 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CytonPro-5000
Cytonsys Inc 510(k) NO: K213524(Traditional)
ATTN: Li-Da Huang PHONE NO : 737 2310369
7801 N. Lamar Blvd, ste C-59 SE DECISION MADE: 10-AUG-22
Austin TX 78752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FORUM
Carl Zeiss Meditec AG 510(k) NO: K213527(Traditional)
ATTN: Stefan Wimmer PHONE NO :
Goeschwitzer Strasse 51-52 SE DECISION MADE: 15-AUG-22
Jena DE 07745 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NOVA RESIN dual cure, self adhesive resin cement
Imicryl Dis Malzemeleri Sanayi Ve 510(k) NO: K213609(Traditional)
ATTN: Hüsamettin Sonmez PHONE NO : 0090 444 7130
Fetih Mahallesi Mahir Sokak No:5/2SE DECISION MADE: 09-AUG-22
Konya TR 42030 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cannulated Screws
Maxxion Medical, LLC 510(k) NO: K213614(Traditional)
ATTN: Guilherme Esteves Pontes PHONE NO : 55 19 38057693
201, South Biscayne Boulevard, SuiSE DECISION MADE: 03-AUG-22
Miami FL 33131 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ClearPoint Maestro Brain Model
ClearPoint Neuro, Inc. 510(k) NO: K213645(Traditional)
ATTN: Pete Piferi PHONE NO : 949 9006833
5 Musick SE DECISION MADE: 08-AUG-22
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SKOUT Software
Iterative Scopes Inc. 510(k) NO: K213686(Traditional)
ATTN: Daniel Wang PHONE NO : 703 3430143
14 Arrow St, 3rd Floor SE DECISION MADE: 12-AUG-22
Cambridge MA 02138 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AI-Rad Companion (Pulmonary)
Siemens Healthcare GmBh 510(k) NO: K213713(Traditional)
ATTN: Lauren Bentley PHONE NO : 610 2416736
40 Liberty Blvd. Mail Code 65-1 SE DECISION MADE: 11-AUG-22
Malvern PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SOL-GUARD Safety Pull Button Collection Set
Sol-Millennium Medical, Inc. 510(k) NO: K213718(Traditional)
ATTN: PJ Pasia PHONE NO : 847 3631264
315 Shawnee North Drive SE DECISION MADE: 30-AUG-22
Suwanee GA 30024 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: dS Sentinelle Breast 16ch 3.0T Coil
Invivo Corporation (Business Trade510(k) NO: K213727(Traditional)
ATTN: Ann Lebar PHONE NO : 414 2176244
3545 SW 47th Ave SE DECISION MADE: 08-AUG-22
Gainesville FL 32608 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: dS Sentinelle Breast 16ch 1.5T Coil
Invivo Corporation (Business Trade510(k) NO: K213735(Traditional)
ATTN: Ann Lebar PHONE NO : 414 2176244
3545 SW 47th Ave SE DECISION MADE: 08-AUG-22
Florida FL 32608 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Lexa PLUS RIS-311
W&H Sterilization s.r.l. 510(k) NO: K213758(Traditional)
ATTN: Paola Zampino PHONE NO : 39 0356 663011
Via Bolgara, 2 SE DECISION MADE: 19-AUG-22
Brusaporto IT 24060 510(k) STATEMENT
DEVICE: Unispace SA Cervical Cage
Edisoninno Co., Ltd. 510(k) NO: K213791(Traditional)
ATTN: So-yeon Jang PHONE NO : 82 31 8606836
20, Sandan-ro 76beon-gil(Rd) SE DECISION MADE: 05-AUG-22
Uijeongbu-si KR 11781 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: StimOnTM Pain Relief System (GM2439)
Gimer Medical Co., Ltd. 510(k) NO: K213802(Traditional)
ATTN: Rex Chang PHONE NO : 886 22 6972680 801
9F.-5 and 9F.-8, No. 97, Sec. 1, XSE DECISION MADE: 26-AUG-22
New Taipei City TW 22175 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FIBERGRAFT Aeridyan Matrix Bone Graft Substitute
Prosidyan, Inc 510(k) NO: K213803(Traditional)
ATTN: Charanpreet S. Bagga PHONE NO : 908 5173666
41 Spring Street Suite #107 SE DECISION MADE: 23-AUG-22
New Providence NJ 07974 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HeRO Graft
Merit Medical Systems, Inc. 510(k) NO: K213845(Traditional)
ATTN: Susan Christensen PHONE NO : 801 2084789
1600 West Merit Parkway SE DECISION MADE: 15-AUG-22
South Jordan UT 84095 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Spineology Navigation Instruments
Spineology Inc. 510(k) NO: K213876(Traditional)
ATTN: Andrew Adams PHONE NO : 651 2568534
7800 3rd Street North, Suite 600 SE DECISION MADE: 05-AUG-22
Saint Paul MN 55128 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ONX Large External Fixation System
OrthoNovis, Inc. 510(k) NO: K213905(Traditional)
ATTN: Ken West PHONE NO : 352 8073306
1 Hargrove Grade, 2F SE DECISION MADE: 25-AUG-22
Palm Coast FL 32137 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Halyard Purple Nitrile, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid
O & M Halyard, Inc. 510(k) NO: K213929(Abbreviated)
ATTN: Steven Dowdley PHONE NO : 678 4518062
1 Edison Drive SE DECISION MADE: 01-AUG-22
Alpharetta GA 30005 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Percent Oxygen Sensors
CareOx, LLC 510(k) NO: K213933(Traditional)
ATTN: Young Kim PHONE NO : 848 7021234
103 Carnegie Center, Suite 300 SE DECISION MADE: 19-AUG-22
Princeton NJ 08540 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Pro Guard Nitrile Powder Free Examination Glove
Medical Glove Co., Ltd 510(k) NO: K213934(Traditional)
ATTN: Teoh Choh Shee PHONE NO : 66 98 0166138
288, Moo 7, Tambon SE DECISION MADE: 06-AUG-22
Lam Thap TH 81190 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Halyard Lavender Nitrile, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution
O & M Halyard, Inc. 510(k) NO: K213937(Abbreviated)
ATTN: Steven Dowdley PHONE NO : 678 4518062
1 Edison Drive SE DECISION MADE: 16-AUG-22
Alpharetta GA 30005 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Powder Free Chloroprene Examination Glove Coloured (Blue, Green)
Careglove Global SDN BHD 510(k) NO: K213993(Traditional)
ATTN: Lim Kwee Shyan PHONE NO : 60 6 6782377
Lot 17479, Lorong Senawang 2/3, OfSE DECISION MADE: 05-AUG-22
Seremban MY 70450 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Beamer AVEO Electrosurgical Generator, Beamer AVEO Argon Module, Beamer AVEO Cart, Beamer AVEO Wired Foot Pedal, Beamer AVEO Argon Pressure Reducer
ConMed Corporation 510(k) NO: K214058(Traditional)
ATTN: Kavita Amin PHONE NO : 508 9482084
525 French Road SE DECISION MADE: 26-AUG-22
Utica NY 13502 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: da Vinci X/Xi (IS4200/IS4000) 8mm Reusable Instruments
Intuitive Surgical, Inc. 510(k) NO: K214095(Traditional)
ATTN: Kunal Gunjal PHONE NO : 909 5252027
1266 Kifer Road, Building 101 SE DECISION MADE: 15-AUG-22
Sunnyvale CA 94086 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Riva Cem Automix
SDI Limited 510(k) NO: K214118(Traditional)
ATTN: Antonella Kotefski PHONE NO : 61 387 277111
3-15 Brunsdon Street SE DECISION MADE: 30-AUG-22
Bayswater AU 3153 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: K220001(Traditional)
ATTN: Abhijit Datta PHONE NO : 858 4554762
12889 Gregg Court SE DECISION MADE: 04-AUG-22
Poway CA 92064 510(k) STATEMENT
DEVICE: Viramed Borrela All-In-One ViraChip Test Kit
Viramed Biotech AG 510(k) NO: K220016(Traditional)
ATTN: Martin Kintrup PHONE NO : 49 89 899336
Behringstrasse 11 SE DECISION MADE: 19-AUG-22
Planegg DE 82152 510(k) STATEMENT
DEVICE: iStent infinite Trabecular Micro-Bypass System, Model iS3
Glaukos Corporation 510(k) NO: K220032(Traditional)
ATTN: David S. Fernquist PHONE NO : 949 3679600 1257
229 Avenida Fabricante SE DECISION MADE: 02-AUG-22
San Clemente CA 92672 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TREVUES (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color)
DK Medivision Co., Ltd. 510(k) NO: K220045(Traditional)
ATTN: Henry Hong PHONE NO : 82 415810100
23 Busong 1-gil, jiksan-eup SE DECISION MADE: 05-AUG-22
Chungcheongnam-do KR 31038 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KLS Martin IPS Distraction
KLS Martin L.P. 510(k) NO: K220050(Traditional)
ATTN: Jennifer Damato PHONE NO : 904 6417746 8005
11201 Saint Johns Industrial ParkwSE DECISION MADE: 11-AUG-22
Jacksonville FL 32246 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable, vinyl examination gloves, Yellow
Dezhou Hengchang Medical Technolog510(k) NO: K220055(Traditional)
ATTN: Jing Li PHONE NO : 86 159 63319855
West Side of South Tiandingfeng RoSE DECISION MADE: 25-AUG-22
Dezhou City CN 251500 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: iSyncWave
iMediSync Inc. 510(k) NO: K220056(Traditional)
ATTN: Seung Wan Kang PHONE NO : 82 2 7477422
3rd FL. 175 Yeoksam-ro, Gangnam-guSE DECISION MADE: 10-AUG-22
Seoul KR 06247 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Safety Insulin Syringes
Berpu Medical Technology Co., Ltd.510(k) NO: K220061(Traditional)
ATTN: David Yu PHONE NO : 86 188 68131179
No. 14 Xingji Road, Yongxiing StreSE DECISION MADE: 23-AUG-22
Wenzhou CN 325000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Medical Surgery Mask, Model:2626-7
Dongguan Missadola Technology Co.,510(k) NO: K220067(Traditional)
ATTN: Adeline Hong PHONE NO : 86 769 88878117
F4,bloc 1,No.289,Nanhuang Road,ZhoSE DECISION MADE: 30-AUG-22
Dongguan CN 523000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMICRYL Composite, Composite Flow Materials
IMICRYL DIS MALZEMELERI SANAYI VE 510(k) NO: K220077(Traditional)
ATTN: Husamettin Sonmez PHONE NO : 444 7130144
Fetih Mahallesi Mahir Sokak No:5/2SE DECISION MADE: 09-AUG-22
Konya TR 42030 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Visibly Digital Acuity Product
Visibly, Inc. 510(k) NO: K220090(Traditional)
ATTN: Paul Foley PHONE NO : 217 9714852
207 E Ohio Street, #233 SE DECISION MADE: 12-AUG-22
Chicago IL 60611 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device
Xiros Ltd 510(k) NO: K220091(Traditional)
ATTN: Steve Curran PHONE NO : 44 113 2387200
Springfield House Lane, WhitehouseSE DECISION MADE: 26-AUG-22
Leeds GB LS17 7UE 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QScreen
PATH MEDICAL GmbH 510(k) NO: K220139(Traditional)
ATTN: Johann Oswald PHONE NO : 49 89 80076502
Landsberger Strasse 65 SE DECISION MADE: 03-AUG-22
Germering DE 82110 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Flexible Ureterorenoscope (Model: US31D-12-EU), Flexible Ureterorenoscope (Model: US31D-12-US)
Shanghai AnQing Medical Instrument510(k) NO: K220159(Traditional)
ATTN: Shuwen Fan PHONE NO : 86 021 61117375
3 & 4 Floor, No.2 Building, 366 HuSE DECISION MADE: 26-AUG-22
Shanghai CN 201201 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Her-2, ER, PR IHControls
Boston Cell Standards, Inc. 510(k) NO: K220163(Traditional)
ATTN: Steven Bogen PHONE NO : 617 6365422
35 Cheryl Drive SE DECISION MADE: 15-AUG-22
Sharon MA 02067-1118 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD MAX Enteric Parasite Panel
Becton, Dickinson and Company 510(k) NO: K220193(Traditional)
ATTN: Joseph Basore PHONE NO : 616 3014068
7 Loveton Circle SE DECISION MADE: 19-AUG-22
Sparks MD 21152 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Medical Nitrile Examination Gloves
Fujian Jixiang Medical Technology 510(k) NO: K220237(Traditional)
ATTN: Jiatian Yang PHONE NO : 86 597 6856383
29 Tingzhou Avenue, Cewu Town, ChaSE DECISION MADE: 01-AUG-22
Longyan CN 366399 510(k) STATEMENT
DEVICE: “POINT” Kinguide Robotic-Assisted Surgical System
Point Robotics MedTech Inc. 510(k) NO: K220241(Traditional)
ATTN: Wayne Kao PHONE NO : 886 2 29130272 165
7F., No.219, Sec.3, Beixin Rd., XiSE DECISION MADE: 09-AUG-22
New Taipei City TW 231 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Dimension EXL LOCI BRAHMS Procalcitonin (PCT)
Siemens Healthcare Diagnostics, In510(k) NO: K220262(Traditional)
ATTN: Amy Tyler PHONE NO : 610 8361390
500 GBC Drive, P.O. Box 6101 Mail SE DECISION MADE: 26-AUG-22
Newark DE 19714 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Picosecond Laser System (Model PS10-A and PS10-B)
Beijing ADSS Development Co., Ltd.510(k) NO: K220268(Traditional)
ATTN: Song Ying PHONE NO : 86 130 51615111
F2,Building 1,Jinyuan Road 36 DaxiSE DECISION MADE: 23-AUG-22
Beijing CN 102628 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Arrow Stiffening Stylet
Arrow International, LLC (a subsid510(k) NO: K220280(Traditional)
ATTN: Fallon Young PHONE NO : 610 9847188
3015 Carrington Mill Blvd SE DECISION MADE: 30-AUG-22
Morrisville NC 27560 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Endoscope Injection Needle
Yangzhou Fartley Medical Instrumen510(k) NO: K220292(Traditional)
ATTN: Tina Han PHONE NO : 0086 150 51101225
Beizhou Road, Lidian Town, GuangliSE DECISION MADE: 19-AUG-22
Yangzhou CN 225106 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MDHearingAid app, MDHearingAid Smart hearing aids
MDHearingAid 510(k) NO: K220303(Traditional)
ATTN: Doug Breaker PHONE NO : 844 9443277
150 N Michigan Avenue Suite 400 SE DECISION MADE: 04-AUG-22
Chicago IL 60601 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Patient Monitor: RespArray
Edan Instruments, Inc. 510(k) NO: K220308(Traditional)
ATTN: Joan. Wei PHONE NO : 86 755 84513592
#15 Jinhui Road, Jinsha Community,SE DECISION MADE: 11-AUG-22
Shenzhen CN 518122 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: G-CAM
Graphenano Dental S.L. 510(k) NO: K220329(Abbreviated)
ATTN: Maria Simon Garcia PHONE NO : 34 965 108102
C/ Pablo Casals , 13 Ba. SE DECISION MADE: 16-AUG-22
Yecla ES 30510 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TeraRecon Neuro
TeraRecon, Inc 510(k) NO: K220349(Traditional)
ATTN: Michael Sosebee PHONE NO : 704 6516828
4309 Emperor Blvd. SE DECISION MADE: 12-AUG-22
Durham NC 27703 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MedCAD AccuShape Titanium Patient-Specific Cranial Implant
MedCAD 510(k) NO: K220357(Traditional)
ATTN: Brian Buss PHONE NO : 214 4538864
501 S 2nd Ave, Suite A-1000 SE DECISION MADE: 26-AUG-22
Dallas TX 75226 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VPS Rhythm DLX Device with TipTracker Technology
Arrow International, LLC (a subsid510(k) NO: K220363(Traditional)
ATTN: Elizabeth Duncan PHONE NO : 866 2466990
3015 Carrington Mill Blvd SE DECISION MADE: 22-AUG-22
Morrisville NC 27560 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Intense Pulsed Light Equipment
Beijing Globalipl Development Co.,510(k) NO: K220385(Traditional)
ATTN: Jun Liu PHONE NO : 86 151 69727366
F-8 Qunyinghui Building, Jinyuan RSE DECISION MADE: 12-AUG-22
Beijing CN 102628 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Blood Lancets
Suzhou Kyuan Medical Apparatus Co.510(k) NO: K220387(Traditional)
ATTN: Shi Ye PHONE NO : 86 512 65995113
Beiqiao Town SE DECISION MADE: 17-AUG-22
Suzhou CN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SmartAdjust(TM) technology
Insulet Corporation 510(k) NO: K220394(Traditional)
ATTN: Alexander Hamad PHONE NO : 978 6002432
100 Nagog Park SE DECISION MADE: 19-AUG-22
Acton MA 01720 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vibe SF Self-Fitting Hearing Aid
WSAUD A/S 510(k) NO: K220403(Traditional)
ATTN: Kristine Klitgaard Pedersen PHONE NO : 0045 21370938
Nymollevej 6 SE DECISION MADE: 12-AUG-22
Lynge DK 3540 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: syngo Application Software (VE21)
Siemens Medical Solution USA, Inc.510(k) NO: K220433(Traditional)
ATTN: Patricia D. Jones PHONE NO : 678 5758832
40 Liberty Boulevard SE DECISION MADE: 16-AUG-22
Malvern PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Blue Eye (TS-905)
The Standard Co., Ltd. 510(k) NO: K220434(Traditional)
ATTN: Sung Nam Kim PHONE NO :
120, Gunpocheomdansaneop 2-ro SE DECISION MADE: 12-AUG-22
Gunpo-si KR 15880 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Materialise Shoulder SystemTM Materialise Shoulder Guide and Models SurgiCase Shoulder Planner
Materialise NV 510(k) NO: K220452(Traditional)
ATTN: Jenny Jones PHONE NO : 32 16 396611
Technologielaan 15 SE DECISION MADE: 17-AUG-22
Leuven BE 3001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEUWAVE Microwave Ablation System and Accessories
NeuWave Medical Inc. 510(k) NO: K220472(Traditional)
ATTN: Mohamed Shariff PHONE NO : 856 4499609
3529 Anderson Street SE DECISION MADE: 11-AUG-22
Madison WI 53704 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Well-Life Mini TENS Stimulator(WL-23XXC/WL-23XXE Series)
Well-Life Healthcare Limited 510(k) NO: K220524(Traditional)
ATTN: Jenny Hsieh PHONE NO : 886 2 22266981
6F., No.168, Lide St., Jhonghe DisSE DECISION MADE: 04-AUG-22
New Taipei City TW 23512 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Tetragraph Neuromuscular Transmission Monitor
Senzime AB 510(k) NO: K220530(Traditional)
ATTN: Johanna Faris PHONE NO : 46 70 5286330
Ulls vag 41 SE DECISION MADE: 17-AUG-22
Uppsala SE 75651 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FAMA Male Latex Condoms
Shanghai Personage Hygiene Product510(k) NO: K220576(Traditional)
ATTN: Haijiang Song PHONE NO : 86 021 69214099
88 Tianchen Road SE DECISION MADE: 05-AUG-22
Qingpu District CN 201700 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ClearCalc Model RADCA V2
Radformation, Inc. 510(k) NO: K220582(Traditional)
ATTN: Kurt Sysock PHONE NO : 844 7233675
335 Madison Avenue, 4th floor SE DECISION MADE: 22-AUG-22
New York NY 10017 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ClearCheck Model RADCC V2
Radformation, Inc. 510(k) NO: K220583(Traditional)
ATTN: Kurt Sysock PHONE NO : 844 7233675
335 Madison Avenue, 4th floor SE DECISION MADE: 23-AUG-22
New York NY 10017 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AutoContour Model RADAC V2
Radformation, Inc. 510(k) NO: K220598(Traditional)
ATTN: Kurt Sysock PHONE NO : 844 7233675
335 Madison Avenue, 4th floor SE DECISION MADE: 24-AUG-22
New York NY 10017 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Medical Safety Hypodermic Needle
Hantech Medical Device Co., Ltd. 510(k) NO: K220603(Traditional)
ATTN: Arnold YANG PHONE NO : 86 189 17368988
No 288, Sanheng Road Changhe IndusSE DECISION MADE: 23-AUG-22
Ningbo CN 315326 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SaliPen
Saliwell Ltd. 510(k) NO: K220618(Traditional)
ATTN: Ben Beiski PHONE NO : 972 50 7256338
3A Hatamar St. SE DECISION MADE: 30-AUG-22
Harutzim IL 6091700 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Bifix Hybrid Abutment Cement
VOCO GmbH 510(k) NO: K220640(Traditional)
ATTN: M. Th. Plaumann PHONE NO : 49 4721 719219
Anton-Flettner-Str. 1-3 SE DECISION MADE: 23-AUG-22
Cuxhaven DE 27472 510(k) STATEMENT
DEVICE: GuideLiner Coast, 5.5F (5270); GuideLiner Coast, 6F (5271); GuideLiner Coast, 7F (5272); GuideLiner Coast, 8F (5273)
Vascular Solutions LLC 510(k) NO: K220647(Special)
ATTN: Steph Pahl PHONE NO : 763 7622641
6464 Sycamore Court N SE DECISION MADE: 18-AUG-22
Maple Grove MN 55369 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OMF ASP System
VHA DEAN 510(k) NO: K220648(Traditional)
ATTN: Beth Ripley PHONE NO : 858 2043375
810 Vermont Ave NW SE DECISION MADE: 11-AUG-22
Washington DC 20420 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Blood Pressure Monitor
Guangdong Transtek Medical Electro510(k) NO: K220676(Traditional)
ATTN: Ada Liang PHONE NO : 86 157 28668528
Zone A, No.105, Dongli Road, TorchSE DECISION MADE: 29-AUG-22
Zhongshan CN 528437 510(k) STATEMENT
DEVICE: Denture Base Polymers
Shandong Huge Dental Material Corp510(k) NO: K220680(Traditional)
ATTN: Maggie Zheng PHONE NO : 086 633 2277268
No. 68 Shanhai Road, Donggang DistSE DECISION MADE: 12-AUG-22
Rizhao City CN 276800 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: uCerv Flux-C 3D Porous Titanium Cervical Interbody
Ulrich Medical USA 510(k) NO: K220696(Traditional)
ATTN: Hans Stover PHONE NO : 636 5190268
18221 Edison Avenue SE DECISION MADE: 19-AUG-22
Chesterfield MO 63005 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Insignia Hip Stem, Restoration Modular 115mm Conical Distal Stem
Stryker 510(k) NO: K220731(Traditional)
ATTN: Gregg Ritter PHONE NO : 352 4942122
325 Corporate Drive SE DECISION MADE: 11-AUG-22
Mahwah NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Consolidated HC Steam Sterilizer
Consolidated Machine Corp. 510(k) NO: K220736(Abbreviated)
ATTN: Arthur Trapotsis PHONE NO : 617 7826072
3 Enterprise Rd, Suite C SE DECISION MADE: 01-AUG-22
Billerica MA 01821 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: K-SHIELD Zen
SB-Kawasumi Laboratories, Inc. 510(k) NO: K220799(Traditional)
ATTN: Shiro Agehama PHONE NO : 81 44 5899750
3-15-4 Tonomachi, Kawasaki-ku, KawSE DECISION MADE: 29-AUG-22
Kanagawa JP 210-8602 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DynaClip® Bone Staple
MedShape, Inc. 510(k) NO: K220812(Traditional)
ATTN: Courtney Kline PHONE NO : 727 5436624
1575 Northside Dr. NW, Suite 440 SE DECISION MADE: 19-AUG-22
Atlanta GA 30318 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BruxZir NOW
Prismatik Dentalcraft, Inc. 510(k) NO: K220816(Traditional)
ATTN: So Hyun Park PHONE NO : 949 8635479
2144 Michelson Drive SE DECISION MADE: 02-AUG-22
Irvine CA 96212 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BrainsWay Deep TMS System
BrainsWay Ltd. 510(k) NO: K220819(Traditional)
ATTN: Ahava Stein PHONE NO : 972 2 5283040
19 Hartom St. (Bynet Bldg) Har HotSE DECISION MADE: 26-AUG-22
Jerusalem IL 9777518 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Arkligners
Arklign Laboratories 510(k) NO: K220835(Traditional)
ATTN: Rex Ho PHONE NO : 800 3611659
2526 Qume Dr Suite 15 SE DECISION MADE: 12-AUG-22
San Jose CA 95131 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HAcancellous PEEK-C Porous HA PEEK Cervical IBF System
Innovasis, Inc. 510(k) NO: K220875(Traditional)
ATTN: Marshall McCarty PHONE NO : 1 801 2612236
614 E 3900 S SE DECISION MADE: 26-AUG-22
Salt Lake City UT 84107 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Mini-ClotTriever Thrombectomy System
Inari Medical 510(k) NO: K220887(Traditional)
ATTN: Ellen Nguyen PHONE NO : 949 4184127
6001 Oak Canyon, Suite 100 SE DECISION MADE: 04-AUG-22
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Brain Biopsy Needle 2.0
PAJUNK GmbH Medizintechnologie 510(k) NO: K220897(Traditional)
ATTN: Christian G. H. Quass PHONE NO : 49 077 049291586
Karl-Hall-Str. 1 SE DECISION MADE: 17-AUG-22
Geisingen DE 78187 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Safety Blood Collection Needles with/without Needle Holder
Anhui Hongyu Wuzhou Medical Manufa510(k) NO: K220900(Traditional)
ATTN: Bingyi Xiang PHONE NO : 86 556 5129666
No.2 Guanyin Road, Taihu Economic SE DECISION MADE: 10-AUG-22
Anqing CN 246400 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WebCeph
AssembleCircle Corp. 510(k) NO: K220903(Traditional)
ATTN: Jang Hoon Kim PHONE NO : 82 31 6970433
R02-ho 8th Floor, 12, DaewangpangySE DECISION MADE: 17-AUG-22
Seongnam-si KR 13487 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Medical image processing software
Hangzhou Deepwise & league of PHD 510(k) NO: K220910(Traditional)
ATTN: Hailong Xu PHONE NO : 86 1352 1047585
Room 705, Building 8, 1818-2 WenyiSE DECISION MADE: 11-AUG-22
Hangzhou CN 311121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QT Scanner 2000 Model A
QT Imaging, Inc. 510(k) NO: K220933(Traditional)
ATTN: John Klock PHONE NO : 415 3022048
3 Hamilton Landing, Suite 160 SE DECISION MADE: 31-AUG-22
Novato CA 94949 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OR3O Dual Mobility System
Smith & Nephew, Inc. 510(k) NO: K220959(Traditional)
ATTN: Rose Beifuss PHONE NO : 385 2532551
7135 Goodlett Farms Parkway SE DECISION MADE: 18-AUG-22
Cordova TN 38016 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Transcutaneous Electrical Nerve Stimulator, Model: KTR-405
Shenzhen Kentro Medical Electronic510(k) NO: K220998(Traditional)
ATTN: Zewu Zhang PHONE NO : 86 0755 33825998
2nd Floor No 11,Shanzhuang Road, XSE DECISION MADE: 24-AUG-22
Shenzhen CN 518100 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Posterior Fusion Plate/HA Posterior Fusion Plate (Minuteman G1), Minuteman G3/HA Minuteman G3, HA Minuteman G3-R, Minuteman G5
Spinal Simplicity LLC 510(k) NO: K221023(Traditional)
ATTN: Adam Rogers PHONE NO : 913 4514414
6363 College Blvd, Ste 320 SE DECISION MADE: 19-AUG-22
Overland Park KS 66211 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Isolation Gown (S, M, L, XL, XXL (Yellow, Blue))
Allmed Medical (Hubei) Protective 510(k) NO: K221027(Traditional)
ATTN: Vince Tian PHONE NO : 86 717 4215906
No.29 Dong Hu Road, Majiadian TownSE DECISION MADE: 12-AUG-22
Zhijiang CN 443299 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Electronic Sphygmomanometers, Model: X1, X2, X5, X6, X7,X8, X11)
Jiangxi AICARE Medical Technology 510(k) NO: K221040(Traditional)
ATTN: Lizhu Xiao PHONE NO : 86 135 30821218
No.6, South Side of Nanhuan Road QSE DECISION MADE: 31-AUG-22
Fuzhou CN 344300 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Zavation VariSync Plate System and VariSync Spacer System
Zavation Medical Products, LLC 510(k) NO: K221049(Traditional)
ATTN: Katie Motley PHONE NO : 601 9191119
220 Lakeland Parkway SE DECISION MADE: 12-AUG-22
Flowood MS 39232 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Viz RV/LV
Viz.ai, Inc. 510(k) NO: K221100(Traditional)
ATTN: Vi Ma PHONE NO : 626 2363138
201 Mission Street, 12th Floor SE DECISION MADE: 29-AUG-22
San Francisco CA 94105 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Actera™ hip system
Conformis Inc. 510(k) NO: K221104(Traditional)
ATTN: Mary Kruitwagen PHONE NO : 781 3459038
600 Technology Park Drive, 4th FloSE DECISION MADE: 04-AUG-22
Billerica MA 01821 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Non-Mydriatic Retinal Camera NW500
Topcon Corporation 510(k) NO: K221111(Traditional)
ATTN: Ryota Kitawaki PHONE NO : 81 3 35582915
75-1 Hasunuma-Cho SE DECISION MADE: 29-AUG-22
Itabashi-Ku JP 174-8580 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CARTO 3 EP Navigation System with Advanced Focus Mapping (AFM)
Biosense Webster, Inc. 510(k) NO: K221112(Traditional)
ATTN: Phuong Park PHONE NO : 949 9234238
31 Technology Drive, Suite 200 SE DECISION MADE: 17-AUG-22
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MANTIS Clip
Boston Scientific Corporation 510(k) NO: K221124(Traditional)
ATTN: Jia Huang PHONE NO : 617 9820126
100 Boston Scientific Way SE DECISION MADE: 04-AUG-22
Marlborough MA 01752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Unistik® 3, sterile single-use safety lancets; Unistik® 3 Value, sterile single-use safety lancets; Abbott SF sterile single-use safety lancets
Owen Mumford Ltd 510(k) NO: K221126(Traditional)
ATTN: Darren Mansell PHONE NO : 44 0 1993812021
Brook Hill SE DECISION MADE: 12-AUG-22
Woodstock GB OX20 1TU 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Tasso+
Tasso, Inc. 510(k) NO: K221131(Traditional)
ATTN: Trish Kan Brown PHONE NO : 206 8224186
1631 15th Ave W, Suite 105 SE DECISION MADE: 12-AUG-22
Seattle WA 98119 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nitrile Exam Gloves (Blue, Black)
Hebei Astro Medical Supply Co., Lt510(k) NO: K221143(Traditional)
ATTN: Ning Zheng PHONE NO : 86 311 85125369
East of Xiaoxixian, West of JingsaSE DECISION MADE: 25-AUG-22
Jinzhou CN 052260 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: JR Medic
JR Engineering & Medical Technolog510(k) NO: K221157(Abbreviated)
ATTN: Ganesan Subramaniam PHONE NO : 603 605 72081
Lot 8 &10, Jalan Zurah 3 & Lot 1&3SE DECISION MADE: 30-AUG-22
Hulu Selangor MY 44200 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Powder Free Nitrile Examination Glove - Blue, Non-Sterile, Tested for use with Chemotherapy Drugs and Fentanyl
Hong Seng Gloves SDN BHD 510(k) NO: K221164(Traditional)
ATTN: Zahari Bin Darus PHONE NO : 604 04 4211555
Lot 97, Jalan 10, Kawasan PerusahaSE DECISION MADE: 30-AUG-22
Sungai Petani MY 08000 510(k) STATEMENT
DEVICE: Erbe's Tubing/Cap Sets
Erbe USA, Inc. 510(k) NO: K221177(Traditional)
ATTN: Jeff Dill PHONE NO : 770 9554400
2225 Northwest Parkway SE DECISION MADE: 11-AUG-22
Marietta GA 30067 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OLIZ LTB-1000A
LTBIO Co., Ltd. 510(k) NO: K221189(Traditional)
ATTN: Min-Ho Kim PHONE NO : 82 31 6081058
1058, B-dong, Seongnam SKV1 Tower,SE DECISION MADE: 29-AUG-22
Seongnam-si KR 13201 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACUSON Juniper Diagnostic Ultrasound System and ACUSON Juniper Select Diagnostic Ultrasound System
Siemens Medical Solutions USA, Inc510(k) NO: K221190(Traditional)
ATTN: Sulgue Choi PHONE NO : 425 281 9898
22010 South East 51st Street SE DECISION MADE: 16-AUG-22
Issaquah WA 98029 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Compass Steerable Needle
Serpex Medical, Inc. 510(k) NO: K221206(Traditional)
ATTN: Sasha Schrode PHONE NO : 609 2549932
3350 Scott Blvd, Suite 37B SE DECISION MADE: 25-AUG-22
Santa Clara CA 95054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Upper Arm Blood Pressure Monitor
Shenzhen Yolanda Technology Co., L510(k) NO: K221212(Traditional)
ATTN: Xuejun Wang PHONE NO : 86 755 21635022
Room 201, Jinfulai Building, No.49SE DECISION MADE: 26-AUG-22
Shenzhen CN 518000 510(k) STATEMENT
DEVICE: EnSite X EP System
Abbott 510(k) NO: K221213(Traditional)
ATTN: Alexandra Agre PHONE NO : 651 7564147
One St. Jude Medical Drive SE DECISION MADE: 18-AUG-22
St. Paul MN 55117 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REAL INTELLIGENCE CORI
Blue Belt Technologies, Inc. 510(k) NO: K221224(Traditional)
ATTN: Corrine Herlinger PHONE NO : 412 6833844 4128
2905 Northwest Blvd., Ste. 40 SE DECISION MADE: 19-AUG-22
Plymouth MN 55441 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FUJIFILM Ultrasonic Endoscope EG-740UT
FUJIFILM Corporation 510(k) NO: K221238(Traditional)
ATTN: Randy Vader PHONE NO : 360 3566821
798 Miyanodai Kaisei-Machi SE DECISION MADE: 19-AUG-22
Ashigarakami-Gun JP 258-8538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SimpliShade Bulk Fill, SimpliShade Bulk Fill Flow
Kerr Corporation 510(k) NO: K221255(Traditional)
ATTN: Haiyan Wei PHONE NO : 714 5167710
1889 W Mission Blvd SE DECISION MADE: 31-AUG-22
Pomona CA 91766 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Recon Steerable Sheath
Serpex Medical, Inc. 510(k) NO: K221302(Traditional)
ATTN: Sasha Schrode PHONE NO : 609 2549932
3350 Scott Blvd, Suite 37B SE DECISION MADE: 15-AUG-22
Santa Clara CA 95054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CONDUIT Lateral Switch Plate
Medos International, SARL 510(k) NO: K221325(Traditional)
ATTN: LiJuan He PHONE NO : 978 4067629
Chemin-Blanc 38 SE DECISION MADE: 25-AUG-22
Le Locle CH 2400 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Bloomi Smooth Water Based Lubricant
The Bloomi Inc.. 510(k) NO: K221328(Traditional)
ATTN: Rebecca Story PHONE NO : 1 510 4105570
74 Royal Ridge Court SE DECISION MADE: 04-AUG-22
Alamo CA 94507 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Avéli
Revelle Aesthetics, Inc. 510(k) NO: K221336(Traditional)
ATTN: Melissa Viotti PHONE NO : 650 3365985
2570 W. El Camino Real, Suite 310 SE DECISION MADE: 05-AUG-22
Mountain View CA 94040 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Transpara 1.7.2
ScreenPoint Medical B.V. 510(k) NO: K221347(Traditional)
ATTN: Robin Barwegen PHONE NO : 31 242 020020
Mercator II, 7th floor, TeornooiveSE DECISION MADE: 03-AUG-22
Nijmegen NL 6525EC 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Non-Sterile Powder Free Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs)
Rubberex Alliance Products Sdn Bhd510(k) NO: K221350(Traditional)
ATTN: Sabri Bin Abdul Hamid PHONE NO : 60 554 82723
Lot 138201 Off 3/4 Mile, Jalan BerSE DECISION MADE: 05-AUG-22
Ipoh MY 31400 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Quantum Perfusion Dual Lumen Cannula 31F, Quantum Perfusion Dual Lumen Cannula 27F, Quantum Perfusion Dual Lumen Cannula 24F, Quantum Perfusion Dual Lumen Cannula 29F, Quantum Perfusion Dual Lumen Cannula 24F-V1, Quantum Perfusion Dual Lumen Cannula 27F-V1, Quantum Perfusion Dual Lumen Cannula 29F-V1, Quantum Perfusion Dual Lumen Cannula 27F-VS, Quantum Perfusion Dual Lumen Cannula 31F-VS
Qura S.r.l. 510(k) NO: K221353(Special)
ATTN: Raffaella Tommasini PHONE NO : 39 0535 1803050
Via di Mezzo 23 SE DECISION MADE: 18-AUG-22
Mirandola IT 41037 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LapBox Tissue Containment Removal System
ARK Surgical, Ltd. 510(k) NO: K221365(Traditional)
ATTN: Stav Tori PHONE NO : 972 4 6098600
13 Wadi El Hadj SE DECISION MADE: 25-AUG-22
Nazareth IL 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KDG Abutments
Keystone Dental Inc. 510(k) NO: K221381(Traditional)
ATTN: Nancy DeAngelo PHONE NO : 1 781 3283660
154 Middlesex Turnpike SE DECISION MADE: 10-AUG-22
Burlington MA 01803 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LiftUp (Ref. Nr.: 200.56.01), LiftUp Kit (Ref. Nr.: 200.56.02)
Ovesco Endoscopy AG 510(k) NO: K221385(Traditional)
ATTN: Marc O. Schurr PHONE NO : 49 7071 98979121
Friedrich-Miescher-Straße 9 SE DECISION MADE: 11-AUG-22
Tuebingen DE 72076 510(k) STATEMENT
DEVICE: Cortera Spinal Fixation System
Surgalign Spine Technologies 510(k) NO: K221403(Traditional)
ATTN: Jessica Jho PHONE NO : 801 4559267
520 Lake Cook Road Suite 315 SE DECISION MADE: 19-AUG-22
Deerfield IL 60015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Neurophet SCALE PET
NEUROPHET, Inc. 510(k) NO: K221405(Traditional)
ATTN: Boreum Yoo PHONE NO : 82 269 547971
12F, 124, Teheran-ro, Gangnam-gu SE DECISION MADE: 05-AUG-22
Seoul KR 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sterile Safety Syringes for Single Use
Shanghai Kindly Enterprise Develop510(k) NO: K221416(Traditional)
ATTN: Liu Hualong PHONE NO : 86 6911 82328125
No. 658 Gaochao Road SE DECISION MADE: 31-AUG-22
Shanghai CN 201803 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: V-Laser
WON TECH Co., Ltd. 510(k) NO: K221427(Special)
ATTN: Hyun Sik Yoon PHONE NO : 82 10 67505346
64 Techno 8-ro, Yuseong-Gu SE DECISION MADE: 24-AUG-22
Daejeon KR 34028 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Customize
3D-Side SA 510(k) NO: K221432(Traditional)
ATTN: Laurent Paul PHONE NO : 32 0 10813548
Rue Andre Dumont 5 SE DECISION MADE: 03-AUG-22
Mont-Saint-Guibert BE 1435 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IPL hair removal
Shenzhen Lizbella Technology Co.,L510(k) NO: K221451(Traditional)
ATTN: Shiwei Zhang PHONE NO : 89 0755 23194813
No.1202, C Block, 3rd Building, HuSE DECISION MADE: 01-AUG-22
Shenzhen CN 518000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IPL Hair Removal Device, model: AI01, AI06, AI08, AI16, AI17
Shenzhen Century Dongyuan Technolo510(k) NO: K221466(Special)
ATTN: He Wang PHONE NO : 86 1379 8450554
Floor 2, Building B1, Gonghe FourtSE DECISION MADE: 12-AUG-22
Shenzhen CN 518104 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INHANCETM Reverse Glenoid Peripheral Posts
Depuy Ireland UC 510(k) NO: K221467(Traditional)
ATTN: Yayoi Fujimaki PHONE NO : 508 8283541
Loughbeg SE DECISION MADE: 31-AUG-22
Ringaskiddy IE 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MyClearALIGN Dental Aligner System
Key Dental Technologies, LLC 510(k) NO: K221475(Traditional)
ATTN: Larry Moray PHONE NO : 919 2592280
920 MLK Blvd Suite 920-B SE DECISION MADE: 31-AUG-22
Chapel Hill NC 27517 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Arthrex FiberTape and TigerTape Cerclage Sutures
Arthrex Inc. 510(k) NO: K221485(Traditional)
ATTN: Kelsey N. Roberts PHONE NO : 1 239 6435553 72257
1370 Creekside Boulevard SE DECISION MADE: 22-AUG-22
Naples FL 34108-1945 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INDEX BPM
Ya Horng Electronic Co., Ltd. 510(k) NO: K221486(Traditional)
ATTN: Jerry Hsu PHONE NO : 8866 593 2201 441
No.35, Shalun, Anding Dist. SE DECISION MADE: 30-AUG-22
Taiwan TW 745 510(k) STATEMENT
DEVICE: NEOVEIL Staple Line Reinforcement
Gunze Limited 510(k) NO: K221487(Special)
ATTN: Hidenori Nishioka PHONE NO : 81 773 428035
46 Natsumegaichi, Aono SE DECISION MADE: 26-AUG-22
Ayabe, Kyoto JP 623-8513 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Blood Lancet
SteriLance Medical (Suzhou) Inc. 510(k) NO: K221507(Traditional)
ATTN: Susan Sun PHONE NO : 86 512 65799308
No.168 PuTuoShan Road, New DistricSE DECISION MADE: 31-AUG-22
Suzhou CN 215153 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Miro3D Wound Matrix
Reprise Biomedical, Inc. 510(k) NO: K221520(Traditional)
ATTN: Herzog Kathy PHONE NO : 612 7994562
17400 Medina Road Suite 100 SE DECISION MADE: 18-AUG-22
Plymouth MN 55447 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Fogarty Dilation Atrioseptostomy Catheter, Miller Balloon Atrioseptostomy Catheter
Edwards Lifesciences, LLC 510(k) NO: K221528(Traditional)
ATTN: Mahvish Iqbal PHONE NO : 949 2504994
1 Edwards Way SE DECISION MADE: 22-AUG-22
Irvine CA 92614 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LimFlow ARC
LimFlow, Inc. 510(k) NO: K221541(Traditional)
ATTN: Zachary Woodson PHONE NO : 1 707 3286522
3031 Tisch Way - 110 Plaza West SE DECISION MADE: 31-AUG-22
San Jose CA 95128 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OneTouch Delica Plus Lancing System
Asahi Polyslider Co., Ltd. 510(k) NO: K221546(Traditional)
ATTN: Yoshitaka Akagi PHONE NO : 81 867 421171
860-2 Misaki SE DECISION MADE: 23-AUG-22
Maniwa JP 719-3226 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: X-ray Flat Panel Detectors (CareView 1800 RF)
CareRay Digital Medical Technology510(k) NO: K221549(Traditional)
ATTN: Xu Wei PHONE NO : 86 512 86860288
A2-201/B3-501, Biobay,218 Xinghu SSE DECISION MADE: 01-AUG-22
Suzhou CN 215123 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HS40 Diagnostic Ultrasound System
Samsung Medison Co., Ltd. 510(k) NO: K221599(Traditional)
ATTN: Jee Young Ju PHONE NO : 82 2 21940861
3366, Hanseo-ro, Nam-myeon, SE DECISION MADE: 22-AUG-22
Hongcheon-gun KR 25108 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SafetiHeel, MediHeel, Novaplus
NSP Tech Pte Ltd 510(k) NO: K221604(Traditional)
ATTN: HC Tan PHONE NO : 65 981 80450
10 Admiralty Street, #02-06 NortSE DECISION MADE: 22-AUG-22
Singapore SG 757695 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Patient Monitor, models LMPLUS-12, LMPLUS-15 and LMPLUS-17
CAF Medical Solutions Inc. 510(k) NO: K221616(Traditional)
ATTN: Oscar Arriaga Yamin PHONE NO : 1 713 6147049
17539 Roberts Road SE DECISION MADE: 01-AUG-22
Hockley TX 77477 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Spine & Trauma Navigation, Spine Navigation, Navigation Software Spine & Trauma, Alignment System Spine, Alignment Software Spine, Cirq Arm System
Brainlab AG 510(k) NO: K221618(Traditional)
ATTN: Chiara Cunico PHONE NO : 49 8999 15680
Olof-Palme-Str.9 SE DECISION MADE: 30-AUG-22
Munich DE 81829 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: exGraft, exGraft Carbon
PECA Labs 510(k) NO: K221628(Traditional)
ATTN: Doug Bernstein PHONE NO : 877 842 2873
4424 Penn Ave, Suite 201 SE DECISION MADE: 04-AUG-22
Pittsburgh PA 15224 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IPL sapphire ice cooling hair remove device
Shenzhen Desida Technology Co., Lt510(k) NO: K221635(Traditional)
ATTN: Shuangcheng Yuan PHONE NO : 86 755 28227189
5th Floor, Building A, Sanmin InduSE DECISION MADE: 31-AUG-22
Shenzhen CN 518109 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Iconic Latex Glove
Iconic medicare sdn bhd 510(k) NO: K221648(Traditional)
ATTN: Tan Cho Chia PHONE NO : 60 4 504159
PMT 798, Lingkaran Cassia Selatan,SE DECISION MADE: 25-AUG-22
Batu Kawan MY 14110 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Dental Impression Material
Chemoment Materials Co.,ltd 510(k) NO: K221668(Traditional)
ATTN: Mabel Lu PHONE NO : 86 551 62329017
No. 546-549, Renhe Industry Town SSE DECISION MADE: 08-AUG-22
Hefei CN 230081 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CellFX® System
Pulse Biosciences, Inc. 510(k) NO: K221671(Traditional)
ATTN: Punam Gollamudi PHONE NO : 415 3054404
3957 Point Eden Way SE DECISION MADE: 01-AUG-22
Hayward CA 94545 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: InstaFill Graft Delivery System, SIGNIFY Bioactive
Globus Medical Inc. 510(k) NO: K221737(Traditional)
ATTN: Jennifer Antonacci PHONE NO : 610 9301800 1861
2560 General Armistead Ave. SE DECISION MADE: 11-AUG-22
Audubon PA 19403 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sterile Posterior Spinal Fixation System
Shanghai REACH Medical Instrument 510(k) NO: K221745(Special)
ATTN: Mingsha Ye PHONE NO : 86 021 54840582
Building 13, No.999 Jiangyue Road SE DECISION MADE: 31-AUG-22
Shanghai CN 201114 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NextGen Pedicle Screw System
CoreLink, LLC 510(k) NO: K221776(Traditional)
ATTN: Steven Mounts PHONE NO : 888 3497808
2072 Fenton Logistics Park SE DECISION MADE: 09-AUG-22
St. Louis MO 63026 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TCL3 Motion Tracking System
TracInnovations A/S 510(k) NO: K221785(Traditional)
ATTN: Stefan Glimberg PHONE NO : 45 53 798545
Brydehusvej 13 SE DECISION MADE: 29-AUG-22
Ballerup DK 2750 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IRIS Pi Q switched Nd YAG laser
Bio-Med USA Inc 510(k) NO: K221789(Traditional)
ATTN: Young Chi PHONE NO : 973 2785222
27 New England Dr SE DECISION MADE: 09-AUG-22
Ramsey NJ 07446 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Acute QC Strut and Components
Smith & Nephew, Inc. 510(k) NO: K221792(Traditional)
ATTN: Amanda Lammey PHONE NO : 901 8331364
7135 Goodlett Farms Parkway SE DECISION MADE: 25-AUG-22
Cordova TN 38016 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OpClear Platform (CU3 DI3), OpClear Control Unit with Footswitch (CS-CU33), OpClear Disposable Procedure Kits (CS-10-00-300, CS-10-30-300, CS-10-00-315, CS-10-30-315, CS-10-00-330, CS-10-30-330, CS-05-00-290, CS-05-30-290), Contd from 3 above: CS-05-00-300, CS-05-30-300, CS-05-00-315, CS-05-30-315
Cipher Surgical Limited 510(k) NO: K221824(Special)
ATTN: Justin Buch PHONE NO : 44 2477 170700
The Venture Centre, Sir William LySE DECISION MADE: 19-AUG-22
Coventry GB CV4 7EZ 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SABER .014 PTA Dilatation Catheter; SABERX .014 PTA Dilatation Catheter
Cordis US Corp. 510(k) NO: K221832(Traditional)
ATTN: Luis Davila PHONE NO : 52 656 1707011 04587
14201 N.W. 60th Avenue SE DECISION MADE: 22-AUG-22
Miami Lakes FL 33014 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CUSA Clarity Ultrasonic Surgical Aspirator System
Integra Lifesciences Corporation 510(k) NO: K221835(Traditional)
ATTN: Alexandra Wells PHONE NO : 609 9036300
1100 Campus Road SE DECISION MADE: 22-AUG-22
Princeton NJ 08540 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Surgical Face Mask (HNFM0103)
Shanghai Hua En Industrial CO LTD 510(k) NO: K221838(Traditional)
ATTN: Lisa Zhao PHONE NO : 86 156 18875177
#30, NO988 Hui Ji Road, Xuanqiao TSE DECISION MADE: 17-AUG-22
Shanghai CN 201314 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TDM Lumbar Interbody Fusion Cage System
TDM Co., Ltd 510(k) NO: K221844(Traditional)
ATTN: Jung Wook Choi PHONE NO : 82 62 9717460
69, Cheomdan Venture So-ro 37 beonSE DECISION MADE: 17-AUG-22
Gwangju KR 61003 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: prodisc C SK, prodisc C Nova, and prodisc C Vivo Instruments
Centinel Spine LLC 510(k) NO: K221848(Traditional)
ATTN: Jessica Staub PHONE NO :
900 Airport Road, Suite 3B SE DECISION MADE: 19-AUG-22
West Chester PA 19380 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GMK 3D Metal Tibial Tray
Medacta International S.A. 510(k) NO: K221850(Traditional)
ATTN: Stefano Baj PHONE NO : 41 91 6966060___
Strada Regina SE DECISION MADE: 23-AUG-22
Castel San Pietro CH CH-6874 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL Catheter
Shockwave Medical, Inc. 510(k) NO: K221852(Traditional)
ATTN: Danica Van PHONE NO : 408 5804471
5403 Betsy Ross Dr SE DECISION MADE: 16-AUG-22
Santa Clara CA 95054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Reprocesses Umbilical Cable
Innovative Health, LLC. 510(k) NO: K221854(Traditional)
ATTN: Rick Ferreira PHONE NO : 877 4003740
1435 North Hayden Road Suite 100 SE DECISION MADE: 06-AUG-22
Scottsdale AZ 85257 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Healstone Accurate (TM) Drug of Abuse Urine Test Cup, Healstone Accurate (TM) Drug of Abuse Urine Test Cup Rx
Healstone Biotech Inc 510(k) NO: K221871(Traditional)
ATTN: Bryan Fang PHONE NO : 604 8002434
Unit 650 - 655 West Kent Avenue NoSE DECISION MADE: 30-AUG-22
Vancouver CA V6P 6T7 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Patient Monitor, models LM-8, LM-10, LM-12 and LM-15
CAF Medical Solutions Inc. 510(k) NO: K221879(Traditional)
ATTN: Oscar Arriaga Yamin PHONE NO : 1713 6147049
17539 Roberts Road SE DECISION MADE: 10-AUG-22
Hockley TX 77477 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Stent Positioning Assistance System (SPAS)
Seven Sons Ltd. 510(k) NO: K221917(Traditional)
ATTN: Nancy Zhang PHONE NO : 31 640 845545
65 Yigal Alon Street SE DECISION MADE: 19-AUG-22
Tel Aviv IL 67443 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARIX Small Fragment System
Jeil Medical Corporation 510(k) NO: K221920(Traditional)
ATTN: Bora Kim PHONE NO : 82 2850 3533
702, 703, 704, 705, 706, 804, 805,SE DECISION MADE: 24-AUG-22
Seoul KR 08378 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Endoscope Model EG-580UT and Endoscope Model EG-580UR
FUJIFILM Corporation 510(k) NO: K221952(Special)
ATTN: Randy Vader PHONE NO : 360 3566821
798 Miyanodai Kaisei-Machi SE DECISION MADE: 04-AUG-22
Ashigarakami-Gun JP 258-8538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Masimo CARESCAPE SpO2 – Masimo with SpHb
Masimo Corporation 510(k) NO: K221953(Special)
ATTN: Unji Lee PHONE NO : 949 5637426
52 Discovery SE DECISION MADE: 04-AUG-22
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Brasseler GEM, Brasseler GEM10, Brasseler GEM15, Brasseler GEM20
RealCloud Imaging Inc. dba RealClo510(k) NO: K221955(Traditional)
ATTN: Douglas A Golay PHONE NO : 712 3013882
2625 North Loop Drive, Suite 2130 SE DECISION MADE: 31-AUG-22
Ames IA 50010 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LINQ II Insertable Cardiac Monitor
Medtronic, Inc. 510(k) NO: K221962(Traditional)
ATTN: Dianna L. Johannson PHONE NO : 763 5262376
8200 Coral Sea Street NE MS-MVS11 SE DECISION MADE: 25-AUG-22
Mounds View MN 55112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Lancing device
SteriLance Medical(Suzhou) Inc. 510(k) NO: K221970(Traditional)
ATTN: Susan Sun PHONE NO : 86 051265 7993089294
No.168 PuTuoShan Road SE DECISION MADE: 30-AUG-22
Suzhou CN 215153 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ultrasound Transmission Gels
Hony Medical Co., Ltd. 510(k) NO: K221999(Traditional)
ATTN: Zhu Huina PHONE NO : 86 159 16327827
No.12,9Road,Changlong Ind.Zone, SE DECISION MADE: 30-AUG-22
Taishan CN 529222 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Dolphin Imaging 12.0
Patterson Dental Supply, Inc 510(k) NO: K222072(Special)
ATTN: Erin Daly PHONE NO : 608 3454888___
Dolphin Imaging & Management SolutSE DECISION MADE: 08-AUG-22
Chatsworth CA 91311 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: aprevo® anterior and lateral lumbar interbody fusion devices, aprevo® transforaminal lumbar interbody fusion devices
Carlsmed, Inc. 510(k) NO: K222082(Special)
ATTN: Karen Liu PHONE NO : 760 7661926
1800 Aston Ave., Ste 100 SE DECISION MADE: 12-AUG-22
Carlsbad CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LimFlow V-Ceiver
LimFlow Inc. 510(k) NO: K222083(Third Party - Traditional)
ATTN: Zachary Woodson PHONE NO : 1 707 3286522
3031 Tisch Way - 110 Plaza West SE DECISION MADE: 09-AUG-22
San Jose CA 95128 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: 1688 4K Camera System with Advanced Imaging Modality
Stryker 510(k) NO: K222130(Special)
ATTN: Marlene Fraga PHONE NO : 928 2949043
5900 Optical Court SE DECISION MADE: 19-AUG-22
San Jose CA 95138 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EzDent-i / E2 / Prora View/ Smart M Viewer
Ewoosoft Co., Ltd 510(k) NO: K222145(Traditional)
ATTN: Young Seok Kim PHONE NO : 82 31 80156172
801-ho, Vatechnetworks Bldg., 13, SE DECISION MADE: 12-AUG-22
Hwaseong-si KR 18449 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Arthrex Knotless FiberTak Biceps Suture Anchor
Arthrex Inc. 510(k) NO: K222161(Special)
ATTN: Kelsey N Roberts PHONE NO : 1 239 6435553 72257
1370 Creekside Boulevard SE DECISION MADE: 11-AUG-22
Naples FL 34108-1945 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FairFix Adjustable Button System
Medacta International SA 510(k) NO: K222169(Special)
ATTN: Stefano Baj PHONE NO : 41 91 6966060
Strada Regina SE DECISION MADE: 16-AUG-22
Castel San Pietro CH CH-6874 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MI View&GO
Siemens Medical Solutions USA, Inc510(k) NO: K222172(Special)
ATTN: Clayton Ginn PHONE NO : 865 8982692
810 Innovation Drive SE DECISION MADE: 19-AUG-22
Knoxville TN 37932 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Baby Gorilla®/Gorilla® Plating System
Paragon 28, Inc. 510(k) NO: K222194(Special)
ATTN: Haylie Hertz PHONE NO : 303 7200017
14445 Grasslands Drive SE DECISION MADE: 19-AUG-22
Englewood CO 80112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ivWatch Model 400
ivWatch, LLC 510(k) NO: K222212(Special)
ATTN: Holly Novak PHONE NO : 855 4892824 7046
700 Tech Center Parkway, Suite 300SE DECISION MADE: 24-AUG-22
Newport News VA 23606 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NeuroStar, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar Advanced Therapy System for Mental Health
Neuronetics, Inc. 510(k) NO: K222230(Special)
ATTN: Amanda Pentecost PHONE NO : 610 6404202
3222 Phoenixville Pike SE DECISION MADE: 24-AUG-22
Malvern PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sherlock 3CG® Tip Positioning System (TPS) Stylet/T-Lock Assembly
Bard Access Systems, Inc. 510(k) NO: K222232(Special)
ATTN: Teresa Do-McCage PHONE NO : 801 5225959
605 North 5600 West SE DECISION MADE: 24-AUG-22
Salt Lake City UT 84116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: miCOR System Lens Fragmentation System
Carl Zeiss Meditec Cataract Techno510(k) NO: K222236(Special)
ATTN: Gary Mocnik PHONE NO : 949 4330413
8748 Technology Way SE DECISION MADE: 24-AUG-22
Reno NV 89521 510(k) STATEMENT
DEVICE: SmartBolus Calculator
Insulet Corporation 510(k) NO: K222239(Traditional)
ATTN: Alexander Hamad PHONE NO : 978 6002432
100 Nagog Park SE DECISION MADE: 19-AUG-22
Acton MA 01720 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BonOs® Inject Bone Cement; NEO Pedicle Screw System™
Neo Medical SA 510(k) NO: K222256(Special)
ATTN: Jonas Larsson PHONE NO : 41 79 4440443
Route de Lausanne 157 A SE DECISION MADE: 26-AUG-22
Villette (Lavaux) CH 1096 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 1.5 T/R Quad Extremity Coil, 1.5T 8CH T/R Knee Coil
Invivo Corporation (Business Trade510(k) NO: K222257(Third Party - Traditional)
ATTN: Connie Pascual PHONE NO : 1 978 6592440
3545 SW 47th Ave. SE DECISION MADE: 23-AUG-22
Gainesville FL 32608 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: Arthrex Self Punching SwiveLock Suture Anchors
Arthrex Inc. 510(k) NO: K222263(Special)
ATTN: Tiffany Mentzel PHONE NO : 1239 6435553 75833
1370 Creekside Boulevard SE DECISION MADE: 26-AUG-22
Naples FL 34108 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: truFreeze Console, PN CC301; Aire PV Passive Venting Catheter, PN CO840703; 16 Fr CDT 5 Pack, PN 2000181; 20Fr CDT 5 Pack, PN ACCCC3CDT05; Active Venting Spray Kit, 20 Fr CDT, PN 2000177; Active Venting Spray Kit 16 Fr CDT, PN 20000516; Rapid AV Catheter 5 Pack, PN 2000184
STERIS Corporation 510(k) NO: K222272(Special)
ATTN: Carroll Martin PHONE NO : 440 3586259
5960 Heisley Road SE DECISION MADE: 18-AUG-22
Mentor OH 44060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FONA XDC
FONA S.r.l 510(k) NO: K222274(Special)
ATTN: Luigi Germano PHONE NO : 39____ 02 45712171__
Via G.Galilei 11 SE DECISION MADE: 23-AUG-22
Assago IT 20057 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BriefCase
Aidoc Medical, Ltd. 510(k) NO: K222277(Special)
ATTN: Amalia Schreier PHONE NO : 972 73 7946870
3 Aminadav St. SE DECISION MADE: 26-AUG-22
Tel Aviv IL 6706703 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LOSPA TKR System Instrumentation, EXULT TKR System Instrumentation
Corentec Co., Ltd. 510(k) NO: K222278(Special)
ATTN: Yoorim Bae PHONE NO : 82 41 4107116
12, Yeongsanhong 1-gil, Ipjang-myeSE DECISION MADE: 26-AUG-22
Cheonan-si KR 31056 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Rusch Intermittent Urethral Catheters
Teleflex Medical 510(k) NO: K222279(Special)
ATTN: Kelly Breheim PHONE NO : 612 5001344
3015 Carrington Mill Blvd SE DECISION MADE: 29-AUG-22
Morrisville NC 27560 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 8ch Wrist Coil
Invivo Corporation (Business Trade510(k) NO: K222325(Third Party - Traditional)
ATTN: Connie Pascual PHONE NO : 1 978 6592440
3545 SW 47th Ave SE DECISION MADE: 31-AUG-22
Gainesville FL 32608 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: DenMat Glutaraldehyde Desensitizer
DenMat Holding, LLC 510(k) NO: K222357(Third Party - Traditional)
ATTN: Murisa Woodlin PHONE NO : 805 3463700 2933
1017 W. Central Avenue SE DECISION MADE: 09-AUG-22
Lompoc CA 93436 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: Salvo® Spine System
Spine Wave, Inc. 510(k) NO: K222362(Special)
ATTN: Ronald K Smith PHONE NO : 203 7121846
Three Enterprise Drive, Suite 210 SE DECISION MADE: 29-AUG-22
Shelton CT 06484 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vantage Galan 3T, MRT-3020, V8.0 with AiCE Reconstruction Processing Unit for MR
Canon Medical Systems Corporation 510(k) NO: K222387(Special)
ATTN: Janine F Reyes PHONE NO : 714 6697853
1385 Shimoshigami SE DECISION MADE: 31-AUG-22
Otawara-shi JP 324-8550 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TERA HARZ DENTURE
Graphy Inc. 510(k) NO: K222414(Third Party - Traditional)
ATTN: Tae-woo Kim PHONE NO : 82 2 8643056
603, #617, Ace Gasan Forhu, 225, GSE DECISION MADE: 11-AUG-22
Seoul KR 08503 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: Nitrile Powder Free Examination Gloves, Tested For Use With Chemotherapy Drugs And Fentanyl Citrate (Dark Blue)
Better Care Plastic Technology Co.510(k) NO: K222449(Traditional)
ATTN: Zhu Chunyan PHONE NO : 86 311 66766067
Fuqian Xi Road, West district of SSE DECISION MADE: 27-AUG-22
Shenze County CN 050000 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, RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP and 7053HP Single Chamber Washer Disinfector
Steris 510(k) NO: K222543(Special)
ATTN: Anthony Piotrkowski PHONE NO : 440 3927437___
5960 Heisley Rd SE DECISION MADE: 25-AUG-22
Mentor OH 44060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set
Centers for Disease Control and Pr510(k) NO: K222558(Special)
ATTN: Julie Villanueva, PhD PHONE NO : 404 6393851
1600 Clifton Road NE, MS-H24-11 SE DECISION MADE: 30-AUG-22
Atlanta GA 30329 510(k) SUMMARY AVAILABLE FROM FDA
TOTAL 510(k)s THIS PERIOD 257
TOTAL WITH SUMMARIES 244
TOTAL WITH STATEMENTS 13