# K895086: Gauze Sponge

- Pathway: 510(k) (Traditional)
- Applicant: Keilei Intl., Inc.
- Decided: Oct 23, 1989 after 76 days
- Product code: EFQ (Gauze/Sponge, Internal)
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K961773: Protec Sterile Gauze Sponge (1996), 0 descendants of its own

Source page: https://510kreport.com/device/K895086
Methodology: https://510kreport.com/methodology