510(k) K254073 ยท FRO Dressing, Wound, Drug
StatSeal Disc
| Applicant | Merit Medical Systems, Inc., South Jordan UT, US |
| Decision | Substantially Equivalent, May 13, 2026 |
| Received | Dec 18, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K254073
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.