510(k) K253609 · QSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics
TRAUMAGEL® 2.0 Hemostatic Gel
| Applicant | Cresilon, Inc., Brooklyn NY, US |
| Decision | Substantially Equivalent, Dec 12, 2025 |
| Received | Nov 18, 2025 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K253609
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.