# K963134: Drain/Slit Sponge (Non-Sterile and Sterile)

- Pathway: 510(k) (Traditional)
- Applicant: Igenics, Inc.
- Decided: Sep 6, 1996 after 25 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. The FDA summary names its predicate without a number.
- (no number) Igenics general use sponges: named in the summary without a submission number
- (no number) Nu Gauze: named in the summary without a submission number
- (no number) Versalon: named in the summary without a submission number

## Indications for use
It is intended that the drain/slit sponges will be used as a dressing around tubes and needles and for other general medical and dental purposes for which cotton gauze has traditionally been used.

Source page: https://510kreport.com/device/K963134
Methodology: https://510kreport.com/methodology