510(k) K022269 ยท GAM Suture, Absorbable, Synthetic, Polyglycolic Acid
COATED VICRYL* (POLYGLACTIN 910) SUTURE
| Applicant | ETHICON, Inc., Somerville NJ, US |
| Decision | Substantially Equivalent, Sep 13, 2002 |
| Received | Jul 15, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K022269
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 14, 2024 | Ethicon, Inc. VICRYL (polyglactin 910) Suture - Indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic surgery, but not for use in cardiovascular and neurological tissue Open, Classified |
GAM | None listed |
| Feb 4, 2020 | Ethicon, Inc. Coated VICRYL (Polyglactin 910) Suture, 18" (45cm) Product Code J497H. The device is a synthetic absorbable sterile surgical suture. Terminated |
GAM | None listed |
| Jun 2, 2006 | Ethicon, Inc. Coated Vicryl (polyglactin 910) suture. Needle Type CTXB Suture size: 1. Vicryl suture is a synthetic absorbable sterile surgical suture comprised of a copolymer made from 90% gycolide and 10%L-lacti Terminated |
GAM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.