510(k) K254188 ยท GAT Suture, Nonabsorbable, Synthetic, Polyethylene
Meniscus Versaflex
| Applicant | GM Dos Reis Industria e Comercio Ltda., Campinas, BR |
| Decision | Substantially Equivalent, Feb 19, 2026 |
| Received | Dec 23, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K254188
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.