# K250550: FUJIFILM Endoscope Model EG-S100XT and VS-1000 Display Unit

- Pathway: 510(k) (Traditional)
- Applicant: Fujifilm Corporation
- Decided: Feb 17, 2026 after 357 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
Longest line of descent: 4 generations back to K853585 (1986). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K954451: Evis 140 System, Olympus America, Inc. (1996) Summary page 5.
- K072957: Evis Exera II 180 System, Olympus Medical Systems Corporation (2008) Summary page 5.

## Indications for use
This product is intended for the visualization of the upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum. This product is a non-sterile, reusable display device designed to display live image data from FUJIFILM single-use endoscope.

Source page: https://510kreport.com/device/K250550
Methodology: https://510kreport.com/methodology