510(k) K050845 ยท GAM Suture, Absorbable, Synthetic, Polyglycolic Acid
MONOCRYL PLUS ANTIBACTERIAL SUTURE
| Applicant | ETHICON, Inc., Somerville NJ, US |
| Decision | Substantially Equivalent, Jun 29, 2005 |
| Received | Apr 4, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K050845
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 12, 2009 | Ethicon, Inc. MONOCRYL Plus Antibacterial (poliglecaprone 25) Suture;
Ethicon, Inc., A Johnson & Johnson Company, Somerville, NJ
Sutures are intended for general soft tissue approximation and/or ligation. Terminated |
GAM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.