# K160275: Fuse Endoscopic System with FuseBox Processor

- Pathway: 510(k) (Traditional)
- Applicant: Endochoice, Inc.
- Decided: Aug 1, 2016 after 181 days
- Product code: PEA (Endoscope, Accessories, Image Post-Processing For Color Enhancement)
- 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: 10 generations back to K921244 (1992). 56 ancestors in all.
No later device cites it as a predicate yet.
3 of 57 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152182: Fuse Gastroscopy System, Endochoice, Inc. (2015) Summary page 4.
- K141598: Fuse Colonoscopy System, Endochoice, Inc. (2014) Summary page 4.

## Indications for use
Fuse Colonoscopy System The Fuse Colonoscope with FuseBox Processor is intended for diagnostic visualization of the digestive tract. The system also provides access for therapeutic interventions using standard endoscopy tools. The system consists of EndoChoice camera heads, endoscopes, video system, light source and other ancillary equipment. 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 system includes Lumos, a digital post processing image enhancement technology. Lumos is intended to be used as an optional adjunct following white light endoscopy and is not intended to replace histopathological sampling as a means of diagnosis. Fuse 1G Gastroscopy System The Fuse 1G Gastroscope with FuseBox Processor is intended for diagnostic visualization of the digestive tract. The system also provides access for therapeutic interventions using standard endoscopy tools. The system consists of EndoChoice camera heads, endoscopes, video system, light source and other ancillary equipment. The Fuse 1G Gastroscope, in conjunction with the FuseBox processor, is indicated for use within the upper digestive tract (including the esophagus, stomach and duodenum). The system includes Lumos, a digital post processing image enhancement technology. Lumos is intended to be used as an optional adjunct following white light endoscopy and is not intended to replace histopathological sampling as a means of diagnosis.

Source page: https://510kreport.com/device/K160275
Methodology: https://510kreport.com/methodology