510(k) K053361 ยท OTO Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed
MODIFICATION TO: MINIMESH POLYPROPYLENE MESH
| Applicant | Mpathy Medical Devices, Ltd., Farfield CT, US |
| Decision | Substantially Equivalent, Feb 6, 2006 |
| Received | Dec 2, 2005 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K053361
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 2, 2012 | Coloplast Manufacturing US, LLC Coloplast, Restorelle DirectFix, Posterior Polypropylene Mesh, Catalogue Number 501460, Rx Only, Manufacturer, Coloplast A/S 3050 Denmark
Restorelle is a ploypropylene mesh that may be used for the Terminated |
FTL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.