# K141598: Fuse Colonoscopy System

- Pathway: 510(k) (Special)
- Applicant: Endochoice, Inc.
- Decided: Sep 30, 2014 after 109 days
- Product code: FDF (Colonoscope And Accessories, Flexible/Rigid)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K921244 (1992). 25 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132839: Fuse 1C Colonoscopy System, Endochoice, Inc. (2014) Summary page 4.

## Most influential descendants
- K160275: Fuse Endoscopic System with FuseBox Processor (2016), 0 descendants of its own

## Recalls of this device
- Dec 18, 2015 · Class II · Z-0694-2016: The bending section of the device may partially separate from the insertion tube. Potential for tissue trauma.

## Indications for use
The Fuse® Colonoscopy System is intended for diagnostic visualization of the digestive tract. The system also provides access for therapeutic interventions using standard endoscopy tools. Fuse® Colonoscopes, in conjunction with the FuseBox™ processor, are indicated for use within the lower digestive tract (including the anus, rectum, sigmoid colon, colon and ileocecal valve) for adult patients. The Fuse® Colonoscopy System consists of EndoChoice camera heads, endoscopes, video system, light source and other ancillary equipment.

Source page: https://510kreport.com/device/K141598
Methodology: https://510kreport.com/methodology