# K240142: FUJIFILM Endoscope Model EG-840N; FUJIFILM Endoscope Model EG-840T; FUJIFILM Endoscope Model EG-840TP

- Pathway: 510(k) (Traditional)
- Applicant: Fujifilm Corporation
- Decided: Sep 4, 2024 after 230 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: 7 generations back to K944759 (1995). 16 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183572: FUJIFILM Endoscope Models EG-760CT, EC-760P-V/L and EC-740T/L, Fujifilm Corporation (2019) Summary page 5.
- K182836: FUJIFILM Endoscope Model EG-740N, Fujifilm Corporation (2019) Summary page 5.
- K172916: FUJIFILM Endoscope Models EG-760R, EG-760Z, EC-760R-V/L and EC-760ZP-V/L, and FUJIFILM Water Tank Model WT-603, Fujifilm Corporation (2018) Summary page 5.
- K183032: FUJIFILM Double Balloon Endoscope EI580BT, Fujifilm Corporation (2019) Summary page 5.

## Most influential descendants
- K243260: FUJIFILM Processor EP-8000; FUJIFILM Endoscope Model EG-860R (2025), 1 descendant of its own
- K261880: FUJIFILM Processor EP-8000;Balloon Controller PB-30;Endoscopy Support Program EW10-VM01 (2026), 0 descendants of its own
- K243512: FUJIFILM Endoscope Model EG-840N; FUJIFILM Endoscope Model EG-840T; FUJIFILM Endoscope Model EG-840TP (2025), 0 descendants of its own

## 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/K240142
Methodology: https://510kreport.com/methodology