# K063860: Thrombigel Thrombin/Gelatin Foam Hemostat

- Pathway: 510(k) (Traditional)
- Applicant: Vascular Solutions, Inc.
- Decided: Feb 13, 2007 after 47 days
- Product code: QSX (Hemostatic Wound Dressing With 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: 6 generations back to K896068 (1990). 7 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053644: Thrombigel Thrombin/Gelatin Foam Hemostat, Vascular Solutions, Inc. (2006) Summary page 5.
- K050511: Thrombigel Thrombin/Gelatin Foam Hemostat, Vascular Solutions, Inc. (2005) Summary page 5.

## Most influential descendants
- K080022: Gel-Sponge Ent, Absorbable Gelatin Sponge, Usp (2008), 0 descendants of its own
- K070938: Thrombi-Paste Thrombin/Gelatin Powder Paste Hemostat (2007), 0 descendants of its own

## Indications for use
The ThrombiGel® thrombin/gelatin foam hemostat is applied topically and is indicated as a trauma dressing for temporary control of moderate to severely bleeding wounds and for the control of surface bleeding from vascular access sites and percutaneous catheters or tubes.

Source page: https://510kreport.com/device/K063860
Methodology: https://510kreport.com/methodology