# K040048: Fujinon Double Balloon Enteroscopy System

- Pathway: 510(k) (Traditional)
- Applicant: Fujinon, Inc.
- Decided: Jun 7, 2004 after 147 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: 1 generation back to K993704 (2000). 1 ancestor in all.
64 later devices descend from it; 10 cite it directly.
0 of 66 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993704: Gastro-Intestinal System EN-410WM, Fujinon, Inc. (2000) Summary page 1.

## Most influential descendants
- K090116: Fujinon Colonoscope for Double Balloon Enterscopy System Model, EC-450B15 (2009), 45 descendants of its own
- K143556: Fujifilm Double Balloon Endoscopes Models EN-530T and EN-580T (2015), 19 descendants of its own
- K052084: Endo-Ease Endoscopic Overtube (2005), 18 descendants of its own
- K162749: FUJIFILM Hood Models DH-28GR, DH-29CR and DH-30CR (2017), 8 descendants of its own
- K162428: DiLumen Endolumenal Interventional Platform (2016), 7 descendants of its own

## Indications for use
The device is intended for the Optical visualization of the upper gastrointestinal tract. This includes the esophagus, stomach, duodenum, and small bowel. It is intended for the observation, diagnosis, and endoscopic treatment.

Source page: https://510kreport.com/device/K040048
Methodology: https://510kreport.com/methodology