# K961773: Protec Sterile Gauze Sponge

- Pathway: 510(k) (Traditional)
- Applicant: Derivadas Degasa S.A. DE C.V.
- Decided: Jul 29, 1996 after 82 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
Longest line of descent: 1 generation back to K895086 (1989). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K895086: Gauze Sponge, Keilei Intl., Inc. (1989) Summary page 1.

## Indications for use
DeGasa Sterile USP Gauze Sponges are used in a hospital setting where sterile gauze is required. The instructions for use by physicians using gauze sponges are exactly the same as the instructions for use found on present labeling for similar products currently on the market.

Source page: https://510kreport.com/device/K961773
Methodology: https://510kreport.com/methodology