510(k) K121612 ยท OTP Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed
ELEVATE PROLAPSE REPAIR SYSTEMS-APICAL NEEDLE PASSER SHEATH MODIFICATION
| Applicant | American Medical Systems, Minnetonka MN, US |
| Decision | Substantially Equivalent, Jul 20, 2012 |
| Received | Jun 1, 2012 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K121612
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.