# K964334: Expandacell Anti-Fog Instrument Wipe (with Alcohol)/(Without)

- Pathway: 510(k) (Traditional)
- Applicant: Shippert Medical Technologies Corp.
- Decided: Dec 9, 1996 after 39 days
- Product code: GCJ (Laparoscope, General & Plastic Surgery)
- Device class: 2
- Regulation: 21 CFR 876.1500
- 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). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K791736: Merocel Instrument Wipe, Xomed, Inc. (1979) Summary page 1.

## Cited in the summary but kept off the family tree
- K923843: Fogless, Sorex Medical (1994). Our OCR of the scanned summary read K923843, FDA’s number for Fogless (Sorex Medical). Its FDA name has none of the distinctive words the summary uses for the device it names, “Anti-Fog Instrument Wipe”. Kept off the family tree. Summary page 1.

Source page: https://510kreport.com/device/K964334
Methodology: https://510kreport.com/methodology