510(k) K010931 ยท OTO Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed
AMS SACRAL COLPOPEXY SLING, MODEL 72403501
| Applicant | American Medical Systems, Inc., Minnetonka MN, US |
| Decision | Substantially Equivalent, Apr 9, 2001 |
| Received | Mar 28, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K010931
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.