510(k) K172565 ยท PWJ Instrumentation, Surgical Mesh, Urogynecologic, Stress Urinary Incontinence
Advantage/Advantage Fit Delivery Device, Lynx Delivery Device, Obtryx Delivery Device (Curved & Halo), Obtryx II Delivery Device (Curved & Halo), Solyx SIS Delivery Device
| Applicant | Boston Scientific Corporation, Marlboro MA, US |
| Decision | Substantially Equivalent, Dec 20, 2017 |
| Received | Aug 25, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K172565
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.