510(k) K211847 ยท OTM Mesh, Surgical, For Stress Urinary Incontinence, Male
AdVance XP Male Sling System
| Applicant | Boston Scientific Corporation, Marborough MA, US |
| Decision | Substantially Equivalent, Dec 20, 2021 |
| Received | Jun 15, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K211847
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.