510(k) K031286 ยท GAM Suture, Absorbable, Synthetic, Polyglycolic Acid
SAFIL AND SAFIL QUICK SYNTHETIC ABSORBABLE SURGICAL SUTURE
| Applicant | Aesculap, Inc., Center Valley PA, US |
| Decision | Substantially Equivalent, May 29, 2003 |
| Received | Apr 23, 2003 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K031286
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 1, 2016 | Aesculap Implant Systems LLC Safil QUI + UNDY 5/0 (1) 45CM DSMP13 Suture Terminated |
GAM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.