510(k) K113004 ยท NEW Suture, Surgical, Absorbable, Polydioxanone
PDS(TM) BARBED SUTURES
| Applicant | ETHICON, Inc., Somerville NJ, US |
| Decision | Substantially Equivalent, Dec 20, 2011 |
| Received | Oct 7, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K113004
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 6, 2013 | Ethicon, Inc. Ethicon Stratafix Symmetric PDS Plus Knotless Tissue Control Device Ethicon LLC Guaynabo, Puerto Rico 00969.
Intended for general soft tissue approximation where use of an absorbable suture is approp Terminated |
NEW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.