# K080022: Gel-Sponge Ent, Absorbable Gelatin Sponge, Usp

- Pathway: 510(k) (Traditional)
- Applicant: Vascular Solutions, Inc.
- Decided: Dec 9, 2008 after 341 days
- Product code: KHJ (Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material))
- Device class: 2
- Regulation: 21 CFR 874.3620
- 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 K896068 (1990). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060878: Gelita-Spon Absorbable Gelatin Sponge, Usp, Curamedical, BV (2006) Summary page 1.
- K063860: Thrombigel Thrombin/Gelatin Foam Hemostat, Vascular Solutions, Inc. (2007) Summary page 1.

## Indications for use
The Gel-Sponge ENT, Absorbable Gelatin Sponge, USP is intended for use during and after ENT surgeries for the control of minimal bleeding by tamponade effect, blood absorption and platelet aggregation.

Source page: https://510kreport.com/device/K080022
Methodology: https://510kreport.com/methodology