# K090116: Fujinon Colonoscope for Double Balloon Enterscopy System Model, EC-450B15

- Pathway: 510(k) (Traditional)
- Applicant: Fujinon, Inc.
- Decided: Apr 22, 2009 after 91 days
- Product code: FDF (Colonoscope 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: 2 generations back to K993704 (2000). 5 ancestors in all.
45 later devices descend from it; 7 cite it directly.
0 of 51 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041903: Fujinon G5 Colonoscopes, Models EC-450HL5 and EC-250HL5, Fujinon, Inc. (2004) Summary page 2.
- K040048: Fujinon Double Balloon Enteroscopy System, Fujinon, Inc. (2004) Summary page 2.

## Most influential descendants
- K143556: Fujifilm Double Balloon Endoscopes Models EN-530T and EN-580T (2015), 19 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
- K092156: Cad 12, Colonoscopy Assist Device (2009), 7 descendants of its own
- K100624: Invendo C20 Colonoscopy System (2012), 6 descendants of its own

## Indications for use
The device is intended for the optical visualization of the gastrointestinal tract. This includes the rectum, large and small intestines. It is intended for observation, diagnosis, and endoscopic treatment.

Source page: https://510kreport.com/device/K090116
Methodology: https://510kreport.com/methodology