# K243512: FUJIFILM Endoscope Model EG-840N; FUJIFILM Endoscope Model EG-840T; FUJIFILM Endoscope Model EG-840TP

- Pathway: 510(k) (Traditional)
- Applicant: Fujifilm Corporation
- Decided: Jun 10, 2025 after 210 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: 8 generations back to K944759 (1995). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K240142: FUJIFILM Endoscope Model EG-840N; FUJIFILM Endoscope Model EG-840T; FUJIFILM Endoscope Model EG-840TP, Fujifilm Corporation (2024) Summary page 5.

## Indications for use
FUJIFILM Endoscope Models EG-840T and EG-840TP is intended for the visualization of the upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum. FUJIFILM Endoscope Model EG-840N 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 can be inserted orally or nasally. Never use this product for any other purposes.

Source page: https://510kreport.com/device/K243512
Methodology: https://510kreport.com/methodology