# K964326: Vision-Sciences Model S-V200 Color Mvideo Flexible Sigmoidoscope with Endosheath System

- Pathway: 510(k) (Traditional)
- Applicant: Vision-Sciences, Inc.
- Decided: Jan 3, 1997 after 65 days
- Product code: FAM (Sigmoidoscope And Accessories, Flexible/Rigid)
- 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 K932843 (1994). 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)
- K932843: Flexible Video Sigmoidoscope System W/Disp. Sheath, Vision-Sciences, Inc. (1994) Summary page 1.

## Cited in the summary but kept off the family tree
- K954704: VS-200 Video Sigmoidoscope, Welch Allyn, Inc. (1996). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
The proposed VSI Model S-V200 Color Video Sigmoidoscope is intended for use to examine the lower bowel tract, and, using additional accessories, to perform various diagnostic and therapeutic procedures.

Source page: https://510kreport.com/device/K964326
Methodology: https://510kreport.com/methodology