510(k) K990952 ยท GAT Suture, Nonabsorbable, Synthetic, Polyethylene
NOVAFIL** AND VASCUFIL** STERILE SYNTHETIC NON-ABSORBABLE SUTURES
| Applicant | United States Surgical, A Division of Tyco Healthc, Norwalk CT, US |
| Decision | Substantially Equivalent, Apr 1, 1999 |
| Received | Mar 22, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K990952
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 25, 2023 | Covidien, LP Novafil Monofilament Polybutester Suture
Product Description:
8886 4002-41 NOVAFIL 3-0 BLU 90CM C14
8886 4400-13 NOVAFIL 6-0 BLU 45CM SBE2
8886 4400-23 NOVAFIL 5-0 BLU 45CM SBE2
8886 440123 NOVAFIL 5 Open, Classified |
GAT | None listed |
| Feb 25, 2023 | Covidien, LP Ti-Cron Coated Braided Polyester Suture
Product Description
88862775-31 TICRON* 4-0 BLU 75CM CV327DA
88862880-41 TICRON* 3-0 WHI 75CM Y31DA
88863012-61 TICRON* 0 BLU 90CM C16 X36
88863015-61 TICRON* 0 Open, Classified |
GAT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.