# K143556: Fujifilm Double Balloon Endoscopes Models EN-530T and EN-580T

- Pathway: 510(k) (Traditional)
- Applicant: Fujifilm Medical Systems U.S.A, Inc.
- Decided: Aug 20, 2015 after 248 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: 3 generations back to K993704 (2000). 6 ancestors in all.
19 later devices descend from it; 7 cite it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040048: Fujinon Double Balloon Enteroscopy System, Fujinon, Inc. (2004) Summary page 4.
- K090116: Fujinon Colonoscope for Double Balloon Enterscopy System Model, EC-450B15, Fujinon, Inc. (2009) Summary page 4.

## Most influential descendants
- K162749: FUJIFILM Hood Models DH-28GR, DH-29CR and DH-30CR (2017), 8 descendants of its own
- K183032: FUJIFILM Double Balloon Endoscope EI580BT (2019), 5 descendants of its own
- K240142: FUJIFILM Endoscope Model EG-840N; FUJIFILM Endoscope Model EG-840T; FUJIFILM Endoscope Model EG-840TP (2024), 3 descendants of its own
- K213195: Balloon BS-3 (2021), 2 descendants of its own
- K193123: FUJIFILM Distal Cap Models 33-40 (2019), 2 descendants of its own

## Indications for use
The Fujifilm Double Balloon Endoscopes are 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/K143556
Methodology: https://510kreport.com/methodology