# K960621: Expandacell Instrument Wipe

- Pathway: 510(k) (Traditional)
- Applicant: Shippert Medical Technologies Corp.
- Decided: Apr 1, 1996 after 48 days
- Product code: GEC (Brush, Scrub, Operating-Room)
- Device class: 1
- Regulation: 21 CFR 878.4800
- 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 K791736 (1979). 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)
- K920355: Specialty Sponges, Ultracell Medical Technologies, Inc. (1992) Summary page 5.
- K791736: Merocel Instrument Wipe, Xomed, Inc. (1979) Summary page 5.
- K891101: Non-Absorbable Gauze, Surgical Sponge & Dressing, Smith & Nephew United, Inc. (1989) Summary page 5.

## Indications for use
The Expandacell Instrument Wipe is a sterile, soft, lintless instrument wipe used to clean delicate instruments during a surgical procedure.

Source page: https://510kreport.com/device/K960621
Methodology: https://510kreport.com/methodology