# K990584: Gauze Sponges: Laparotomy Sponge, X-Ray Detectable

- Pathway: 510(k) (Traditional)
- Applicant: Broadline Medical Industries
- Decided: Apr 23, 1999 after 59 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The intended uses of gauze sponges are absorption of blood and body fluids, wound dressing, prepping and scrubbing, and debridement. This product is patient contacting material.

Source page: https://510kreport.com/device/K990584
Methodology: https://510kreport.com/methodology