# K984187: Crosstex Non-Woven Sponges

- Pathway: 510(k) (Traditional)
- Applicant: Crosstex Intl.
- Decided: Feb 18, 1999 after 87 days
- Product code: EFQ (Gauze/Sponge, Internal)
- Device class: U
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K812736 (1981). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K821501: Sterile Tracheostomy Care Kit, Pro-Pak (1982)
- K830473: Nova Gauze, American Threshold Industries, Inc. (1983) Summary page 1.
- K812736: Softcare Barrier Wet Dressing, The Kendal Co. (1981) Summary page 1.

## Recalls of this device
- Mar 22, 2022 · Class II · Z-1119-2022: Product not approved for release for US distribution
- Mar 22, 2022 · Class II · Z-1118-2022: Product not approved for release for US distribution

## Indications for use
Crosstex Non-Woven Sponges are intended, for medical purposes, to be placed directly on a patient's wound or burn to absorb excess body fluids or exudate.

Source page: https://510kreport.com/device/K984187
Methodology: https://510kreport.com/methodology