# K920355: Specialty Sponges

- Pathway: 510(k) (Traditional)
- Applicant: Ultracell Medical Technologies, Inc.
- Decided: Aug 6, 1992 after 192 days
- Product code: GDY (Gauze/Sponge, Internal, X-Ray Detectable)
- Device class: 1
- Regulation: 21 CFR 878.4450
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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.

## Most influential descendants
- K960621: Expandacell Instrument Wipe (1996), 0 descendants of its own

Source page: https://510kreport.com/device/K920355
Methodology: https://510kreport.com/methodology