510(k) K131229 ยท OTN Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
SPARC SYSTEM AND MONARC, MONARC, AND MONARC C SYSTEMS
| Applicant | American Medical Systems, Minnetonka MN, US |
| Decision | Substantially Equivalent, Dec 5, 2013 |
| Received | Apr 30, 2013 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K131229
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 16, 2014 | American Medical Systems, Inc. AMS Monarc + Subfascial Hammock with Tensioning Suture REF 72404193 and AMS Monarc C Subfascial Hammock with Tensioning Suture REF 72404195, Sterilized Using Ethylene Oxide.
The Monarc + and Monarc C Terminated |
OTN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.