The following data is part of a premarket notification filed by Ethicon, Inc with the FDA for Gynecare Tvt Abdominal Guides And Couplers, Gynecare Tvt Reuseable Introducer, Gynecare Tvt Reusable Rigid Catheter Guide.
| Device ID | K173162 |
| 510k Number | K173162 |
| Device Name: | GYNECARE TVT Abdominal Guides And Couplers, GYNECARE TVT Reuseable Introducer, GYNECARE TVT Reusable Rigid Catheter Guide |
| Classification | Instrumentation, Surgical Mesh, Urogynecologic, Stress Urinary Incontinence |
| Applicant | Ethicon, Inc P.O. Box 151, Route 22 West Somerville, NJ 08876 |
| Contact | Julie Tom Wing |
| Correspondent | Julie Tom Wing Ethicon, Inc P.O. Box 151, Route 22 West Somerville, NJ 08876 |
| Product Code | PWJ |
| CFR Regulation Number | 884.4910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-29 |
| Decision Date | 2018-06-28 |