510(k) K181151 ยท PWJ Instrumentation, Surgical Mesh, Urogynecologic, Stress Urinary Incontinence
GYNECARE TVT Abbrevo Continence System; GYNECARE TVT Obturator Continence System
| Applicant | ETHICON, Inc., Somerville NJ, US |
| Decision | Substantially Equivalent, Aug 10, 2018 |
| Received | May 1, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K181151
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.