K253609 is an FDA 510(k) clearance for the TRAUMAGEL® 2.0 Hemostatic Gel. This device is classified as a Hemostatic Wound Dressing Without Thrombin Or Other Biologics.
Submitted by Cresilon, Inc. (Brooklyn, US). The FDA issued a Cleared decision on December 12, 2025, 24 days after receiving the submission on November 18, 2025.
This device falls under the General & Plastic Surgery FDA review panel. To Temporarily Control Bleeding And Cover External Wounds..
| 510(k) Number | K253609 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 18, 2025 |
| Decision Date | December 12, 2025 |
| Days to Decision | 24 days |
| Submission Type | Special |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | QSY - Hemostatic Wound Dressing Without Thrombin Or Other Biologics |
| Device Class | - |
| Definition | To Temporarily Control Bleeding And Cover External Wounds. |