# K051911: Gelita-Spon

- Pathway: 510(k) (Traditional)
- Applicant: Curamedical, BV
- Decided: Dec 6, 2005 after 145 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: 1 generation back to K041381 (2004). 1 ancestor in all.
2 later devices descend 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)
- K041381: Meropack Bioresorbable Nasal Packing and Sinus Stent, Medtronic Xomed, Inc. (2004) Summary page 3.

## Cited in the summary but kept off the family tree
- K021397: Embosphere Microspheres and Embogold Microspheres for Use in Uterine Fibroid Embolization, Biosphere Medical, Inc. (2002). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K060878: Gelita-Spon Absorbable Gelatin Sponge, Usp (2006), 1 descendant of its own
- K080022: Gel-Sponge Ent, Absorbable Gelatin Sponge, Usp (2008), 0 descendants of its own

## Indications for use
Gelita-Spon® Absorbable Gelatin Sponge 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/K051911
Methodology: https://510kreport.com/methodology