# K973558: Visual Endoscopic Non-Alcohol Ultracell Sponge (Venus)

- Pathway: 510(k) (Traditional)
- Applicant: Ultracell Medical Technologies, Inc.
- Decided: Nov 24, 1997 after 66 days
- Product code: FEB (Accessories, Cleaning, For Endoscope)
- 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
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 no predicate by number.

## Indications for use
This product is designed to provide a direct method to remove fog from the endoscope and laparoscope.

Source page: https://510kreport.com/device/K973558
Methodology: https://510kreport.com/methodology