510(k) K173162 ยท PWJ Instrumentation, Surgical Mesh, Urogynecologic, Stress Urinary Incontinence
GYNECARE TVT Abdominal Guides and Couplers, GYNECARE TVT Reuseable Introducer, GYNECARE TVT Reusable Rigid Catheter Guide
| Applicant | ETHICON, Inc., Somerville NJ, US |
| Decision | Substantially Equivalent, Jun 28, 2018 |
| Received | Sep 29, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K173162
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.