510(k) K981935 ยท GAM Suture, Absorbable, Synthetic, Polyglycolic Acid
POLYSORB SUTURE
| Applicant | United States Surgical, A Division of Tyco Healthc, Norwalk CT, US |
| Decision | Substantially Equivalent, Jun 25, 1998 |
| Received | Jun 2, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K981935
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 15, 2018 | Covidien LLC Polysorb Braided Absorbable Suture 1 36" 90 cm
Undyed GS-21, Product Number CL-955 Terminated |
GAM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.