510(k) K231549 ยท OTN Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System
| Applicant | Boston Scientific Corporation, Marlboro MA, US |
| Decision | Substantially Equivalent, Jun 29, 2023 |
| Received | May 30, 2023 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K231549
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.