510(k) K201686 · OTN Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
GYNECARE TVT System, GYNECARE TVT with Abdominal Guides System, GYNECARE TVT Introducer and Catheter Guide, GYNECARE TVT EXACT Continence System and Trocar, GYNECARE TVT Obturator System and Passers and Winged Guide, GYNECARE TVT ABBREVO Continence System and Passers and Winged Guide
| Applicant | ETHICON, Inc., Somerville NJ, US |
| Decision | Substantially Equivalent, Sep 17, 2020 |
| Received | Jun 22, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K201686
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.