K253609 - TRAUMAGEL® 2.0 Hemostatic Gel (FDA 510(k) Clearance)

K253609 is an FDA 510(k) clearance for the TRAUMAGEL® 2.0 Hemostatic Gel. Classified as Hemostatic Wound Dressing Without Thrombin Or Other Biologics (product code QSY).

Submitted by Cresilon, Inc. (Brooklyn, US). The FDA issued a Cleared decision on December 12, 2025 after a review of 24 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

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