510(k) K050947 ยท GAW Suture, Nonabsorbable, Synthetic, Polypropylene
MODIFICATION TO: MODIFIED USS POLYPROPYLENE SUTURE
| Applicant | United States Surgical, A Division of Tyco Healthc, Norwalk CT, US |
| Decision | Substantially Equivalent, Jun 1, 2005 |
| Received | Apr 15, 2005 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K050947
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 7, 2026 | Covidien, LP Surgipro II
S8698GX SURGIPRO II BL 5/0 18 P-13
S8698GX Open, Classified |
GAW | None listed |
| Feb 25, 2023 | Covidien, LP Surgipro II Monofilament Polypropylene Sutures
Product Description Model Number
VP-421X SURGIPRO*II 4-0 90CM V20 DA7P VP421X
VP-435-X SURGIPRO II 4-0 90CM KV5 DA7P VP435X
VP-541X SURGIPRO*II 4-0 BLU 1 Open, Classified |
GAW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.