510(k) K253879 ยท NEW Suture, Surgical, Absorbable, Polydioxanone
MONOFIX PDO
| Applicant | Samyang Holdings Corporation, Daedeok-Gu, KR |
| Decision | Substantially Equivalent, Aug 25, 2026 |
| Received | Dec 4, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253879
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.