510(k) K013718 ยท OTO Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed
GYNEMESH PROLENE SOFT (POLYPROPYLENE) NONABSORBABLE SYNTHETIC SURGICAL MESH FOR PELVIC FLOOR REPAIR
| Applicant | Gynecare, A Div. of Ethicon, Inc., Somerville NJ, US |
| Decision | Substantially Equivalent, Jan 8, 2002 |
| Received | Nov 8, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K013718
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 10, 2007 | Ethicon, Inc. Gynecare PROLIFT Total Pelvic Repair System
PFRT01
Ethicon
Deutschland Terminated |
FTM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.