# K221551: FUJIFILM Endoscope Model EI-740D/S

- Pathway: 510(k) (Traditional)
- Applicant: Fujifilm Corporaton
- Decided: Jan 27, 2023 after 241 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: 5 generations back to K944759 (1995). 7 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210162: Endoscope Model EI-740D/S, Fujifilm Corporation (2021) Summary page 4.

## Most influential descendants
- K260824: Gastrointestinal Videoscope Olympus GIF-2T1500 (2026), 0 descendants of its own
- K233321: Double Balloon Endoscope  EN-840T, Over-tube TS-1214C (2024), 0 descendants of its own

## Indications for use
FUJIFILM Endoscope Model EI-740D/S 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 device is also intended for the visualization of the lower digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the rectum and sigmoid colon. Never use this product for any other purposes.

Source page: https://510kreport.com/device/K221551
Methodology: https://510kreport.com/methodology