# K971734: VG 200 Video Gastroscope

- Pathway: 510(k) (Traditional)
- Applicant: Welch Allyn, Inc.
- Decided: Jul 29, 1997 after 78 days
- Product code: FDS (Gastroscope 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
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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The VideoGastroscope 44 is used for Esophagogastroduodenoscopy (EGD), the internal examination of the upper gastrointestinal tract. The instrument is passed via the mouth and pharynx through the lumen of the esophagus, stomach, and pylorus to the proximal portion of the duodenum. Medical Indications Include: Confirm upper G.I. radiologic findings Biopsy of known or suspected abnormalities Identify the source of acute upper G.I. hemorrhage Monitor the status of chronic disease (e.g., ulcers) Therapeutic uses (e.g. removal of foreign bodies, stricture, dilatation, etc.)

Source page: https://510kreport.com/device/K971734
Methodology: https://510kreport.com/methodology