Panels › Obstetrics/Gynecology › Product code PWJ · Class 2
Instrumentation, Surgical Mesh, Urogynecologic, Stress Urinary Incontinence
Regulation 884.4910
0510(k)s in 12 months (5 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in PWJ
| Company | 510(k)s | Recalls |
|---|---|---|
| ETHICON, Inc. | 3 | 0 |
| Boston Scientific Corporation | 1 | 0 |
| Caldera Medical, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 10, 2018 | K181151 | GYNECARE TVT Abbrevo Continence System; GYNECARE TVT Obturator Continence System ETHICON, Inc. | PWJ |
| Jul 6, 2018 | K173019 | GYNECARE TVT Reusable Introducer, GYNECARE TVT Reusable Rigid Catheter Guide, GYNECARE TVT EXACT Continence System Troca ETHICON, Inc. | PWJ |
| Jun 28, 2018 | K173162 | GYNECARE TVT Abdominal Guides and Couplers, GYNECARE TVT Reuseable Introducer, GYNECARE TVT Reusable Rigid Catheter Guid ETHICON, Inc. | PWJ |
| May 4, 2018 | K172614 | Caldera Medical Transobturator Helical Introducer, Left; Caldera Medical Transobturator Helical Introducer, Right; Calde Caldera Medical, Inc. | PWJ |
| Dec 20, 2017 | K172565 | Advantage/Advantage Fit Delivery Device, Lynx Delivery Device, Obtryx Delivery Device (Curved & Halo), Obtryx II Deliver Boston Scientific Corporation | PWJ |
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