# K183032: FUJIFILM Double Balloon Endoscope EI580BT

- Pathway: 510(k) (Traditional)
- Applicant: Fujifilm Corporation
- Decided: Jun 24, 2019 after 235 days
- Product code: FDA (Enteroscope And Accessories)
- 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 K993704 (2000). 7 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143556: Fujifilm Double Balloon Endoscopes Models EN-530T and EN-580T, Fujifilm Medical Systems U.S.A, Inc. (2015) Summary page 4.

## Most influential descendants
- K240142: FUJIFILM Endoscope Model EG-840N; FUJIFILM Endoscope Model EG-840T; FUJIFILM Endoscope Model EG-840TP (2024), 3 descendants of its own
- 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
- K233321: Double Balloon Endoscope  EN-840T, Over-tube TS-1214C (2024), 0 descendants of its own

## Indications for use
This device is intended for the visualization of the upper and lower digestive tracts, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, duodenum, small intestine, large intestine, and rectum.

Source page: https://510kreport.com/device/K183032
Methodology: https://510kreport.com/methodology