510(k) K946271 ยท GAM Suture, Absorbable, Synthetic, Polyglycolic Acid
VICRYO* (POLYGLACTIN 910) BRAIDED COATED AND UNCOATED SYNTHETIC ABSORBABLE SUTURE, DYED & UNDYED, BRAIDED AND MONOFILAMT
| Applicant | ETHICON, Inc., Somerville NJ, US |
| Decision | Substantially Equivalent, Jun 15, 1995 |
| Received | Dec 23, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K946271
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 12, 2009 | Ethicon, Inc. Coated VICRYL (Polyglactin 910) Suture, Ethicon Inc., A Johnson & Johnson Company, Somerville, NJ 08876
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.