510(k) K974299 ยท GAM Suture, Absorbable, Synthetic, Polyglycolic Acid
PANACRYL
| Applicant | ETHICON, Inc., Somerville NJ, US |
| Decision | Substantially Equivalent, Feb 13, 1998 |
| Received | Nov 17, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K974299
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 27, 2006 | Ethicon, Inc. Panacryl Synthetic Absorbable Suture. Poly(L-lactide/glycolide) Suture. Undyed (white), braided, this suture is a synthetic absorbable sterile surgical suture composed of a copolymer of 95% lactide Terminated |
GAM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.