510(k) K022715 ยท GAM Suture, Absorbable, Synthetic, Polyglycolic Acid
COATED VICRYL PLUS ANTIMICROBIAL (POLYGLACTIN 910) SUTURE
| Applicant | ETHICON, Inc., Somerville NJ, US |
| Decision | Substantially Equivalent, Dec 19, 2002 |
| Received | Aug 15, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K022715
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 12, 2019 | Ethicon, Inc. VICRYL Sutures
VICRYL SUTURE 18"(45CM) 0 VIO
VICRYL SUTURE 18"(45CM) 4-0 UND
VICRYL SUTURE 18"(45CM) 2-0 VIO
VICRYL SUTURE 18"(45CM) 0 VIO
VICRYL SUTURE 18"(45CM) 2-0 VIO
VICRYL CT VIO 8X18IN 0 S/A CT Terminated |
GAM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.