510(k) K253290 ยท PGZ Non-Absorbable, Expandable, Hemostatic Sponge For Temporary Internal Use
XSTAT P15
| Applicant | Revmedx, Inc., Wilsonville OR, US |
| Decision | Substantially Equivalent, Nov 12, 2025 |
| Received | Sep 29, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253290
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.