510(k) K900531 ยท GAR Suture, Nonabsorbable, Synthetic, Polyamide
NONABSORBABLE NYLON SURGICAL SUTURE*
| Applicant | United States Surgical, A Division of Tyco Healthc, Norwalk CT, US |
| Decision | Substantially Equivalent for Some Indications, Jul 5, 1990 |
| Received | Feb 5, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K900531
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 25, 2023 | Covidien, LP Monofilament Nylon Suture (McKesson Branded) and Coated Braided Silk Suture (McKesson Branded)
(1) S661GX 5-0 NYLON 18 DS18
(2)S683GX 4-0 SILK 18 DS18
(3) S683GX 4-0 SILK 18 DS18 Open, Classified |
GAR | None listed |
| Feb 25, 2023 | Covidien, LP Monosof Monofilament Nylon sutures:
Product Description
CN-724 MONOSOF* 1 BLK 100CM GS25 X36
CN-791 MONOSOF* 2-0 BLK 100CM GCC90X36
CN-791-12 MONOSOF* 2-0 BLK 100CM GCC90
C Open, Classified |
GAR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.