510(k) K253394 · GAM Suture, Absorbable, Synthetic, Polyglycolic Acid
Coated VICRYL (Polyglactin 910) Plus Antibacterial Suture
| Applicant | ETHICON, Inc., Raritan NJ, US |
| Decision | Substantially Equivalent, Jun 25, 2026 |
| Received | Sep 30, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253394
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.