# K060878: Gelita-Spon Absorbable Gelatin Sponge, Usp

- Pathway: 510(k) (Special)
- Applicant: Curamedical, BV
- Decided: Apr 13, 2006 after 13 days
- Product code: KHJ (Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material))
- Device class: 2
- Regulation: 21 CFR 874.3620
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K041381 (2004). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051911: Gelita-Spon, Curamedical, BV (2005) Summary page 3.

## Most influential descendants
- K080022: Gel-Sponge Ent, Absorbable Gelatin Sponge, Usp (2008), 0 descendants of its own

## Recalls of this device
- Jul 27, 2022 · Class II · Z-1768-2022: In routine bioburden testing, higher than acceptable levels of Endotoxins were observed.

## Indications for use
Gelita-Spon® Absorbable Gelatin Sponge, USP is indicated for use to control minimal bleeding by tamponade effect, blood absorption and platelet aggregation following ENT surgery and also to prevent adhesions in the nasal cavity.

Source page: https://510kreport.com/device/K060878
Methodology: https://510kreport.com/methodology