510(k) K033746 ยท GAM Suture, Absorbable, Synthetic, Polyglycolic Acid
MODIFIED COATED VICRYL* RAPIDE (POLYGLACTIN 910) SUTURE
| Applicant | ETHICON, Inc., Somerville NJ, US |
| Decision | Substantially Equivalent, Dec 18, 2003 |
| Received | Dec 1, 2003 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K033746
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 17, 2017 | Ethicon, Inc. Coated VICRYL RAPIDETM (Polyglactin 910) Suture Terminated |
GAM | None listed |
| May 18, 2010 | Ethicon, Inc. Coated VICRYL RAPIDE (polyglactin 910) Braided Coated Synthetic Absorbable Suture, Undyed.
Intended use: Soft Tissue approximation. Terminated |
GAM | None listed |
| Oct 2, 2008 | Ethicon, Inc. VICRYL RAPIDE (polyglactin 910) Braided Coated Synthetic Absorbable Suture, Undyed, Non-USP.
Ethicon, Inc., a Johnson & Johnson Co.,Somerville, NJ 08876
The product is used for Soft Tissue approximat Terminated |
GAM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.