# K253609: TRAUMAGEL® 2.0 Hemostatic Gel

- Pathway: 510(k) (Special)
- Applicant: Cresilon, Inc.
- Decided: Dec 12, 2025 after 24 days
- Product code: QSY (Hemostatic Wound Dressing Without Thrombin Or Other Biologics)
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K972914 (1997). 19 ancestors in all.
No later device cites it as a predicate yet.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K240713: Traumagel®, Cresilon, Inc. (2024) Summary page 6.
- K213652: Cresilon Hemostatic Gel, CHG, Cresilon Hemostatic Gel (CHG), Cresilon, Inc. (2023) Summary page 6.

## Indications for use
TRAUAMGEL® 2.0 is a hemostatic gel indicated for temporary external use for controlling moderate to severe bleeding.

Source page: https://510kreport.com/device/K253609
Methodology: https://510kreport.com/methodology