# K962972: Surgicade Gauze Sponge

- Pathway: 510(k) (Traditional)
- Applicant: Accunex Canada,Inc.
- Decided: Oct 11, 1996 after 72 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 K922055 (1992). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K922055: Sterile and Non-Sterile Gauze Sponges, Team Mfg., Inc. (1992) Summary page 1.
- K942070: Lorrex Cover Sponges STERILE2'S and Non-Sterile, Lorrex Health Products (1994) Summary page 1.

## Indications for use
Control bleeding, absorb body fluids, and protect wounds from contamination.

Source page: https://510kreport.com/device/K962972
Methodology: https://510kreport.com/methodology