510(k) K963253 ยท GAM Suture, Absorbable, Synthetic, Polyglycolic Acid
SYNTHETIC ABSORBABLE SURGICAL SUTURE
| Applicant | United States Surgical, A Division of Tyco Healthc, Norwalk CT, US |
| Decision | Substantially Equivalent, Oct 8, 1996 |
| Received | Aug 19, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K963253
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 3, 2017 | Medtronic Sutures. POLYSORB: POLSORB 0 18 U/D PRECUT 126R, Item Number: L4; POLSORB 0 18 VIO PRECUT 226T; Item Number: L14; POLSORB 0 30 VIO PRECUT 227C, Item Number: L404;
POLSORB 1 18 VIO PRECUT 122J; Item Terminated |
GAM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.