# K152182: Fuse Gastroscopy System

- Pathway: 510(k) (Special)
- Applicant: Endochoice, Inc.
- Decided: Dec 10, 2015 after 127 days
- Product code: FDS (Gastroscope 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: 9 generations back to K931154 (1993). 53 ancestors in all.
1 later device descends from it; 1 cites it directly.
3 of 55 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131422: Peerscope System, Endochoice, Inc. (2013) Summary page 4.

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

## Indications for use
The Fuse Gastroscopy System is intended for diagnostic visualization of the digestive tract. The system also provides access for therapeutic interventions using standard endoscopy tools. The Fuse Gastroscopy System is indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum). The Fuse Gastroscopy System consists of camera heads, endoscopes, video system, light source and other ancillary equipment.

Source page: https://510kreport.com/device/K152182
Methodology: https://510kreport.com/methodology