# K132839: Fuse 1C Colonoscopy System

- Pathway: 510(k) (Traditional)
- Applicant: Endochoice, Inc.
- Decided: Feb 6, 2014 after 149 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: 8 generations back to K921244 (1992). 24 ancestors in all.
2 later devices descend 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)
- K130718: Peerscope System, Peermedical, Ltd. (2013) Summary page 2.

## Most influential descendants
- K141598: Fuse Colonoscopy System (2014), 1 descendant of its own
- K160275: Fuse Endoscopic System with FuseBox Processor (2016), 0 descendants of its own

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

Source page: https://510kreport.com/device/K132839
Methodology: https://510kreport.com/methodology