# K192704: Endofresh Digestive Endoscopy System

- Pathway: 510(k) (Traditional)
- Applicant: Huizhou Xzing Technology Co., Ltd.
- Decided: Sep 2, 2020 after 341 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: 8 generations back to K931154 (1993). 28 ancestors in all.
No later device cites it as a predicate yet.
3 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100584: Evis Exeraii 180 System, Olympus Medical Systems Corporation (2010) Summary page 5.

## Indications for use
XZING-W200B Disposable GI Endoscope The disposable GI endoscope (XZING-W200B) is designed to be used with XZING-S2 Camera System, monitor and other peripheral device for endoscopic observation, diagnosis and treatment of the adult upper gastrointestinal tract. It is a single use disposable device and cannot be reused. XZING-C200B Disposable Colonoscope The Disposable Colonoscope (XZING-C200B) is designed to be used with XZING-S2 Camera System, monitor and other peripheral device for electronic colonoscope observation, diagnosis and treatment of the adult lower digestive tract (including the anus, rectum, colon and ileocecal segment). It is a single use disposable device and cannot be reused. XZING-S2 Camera System The Camera System is designed to be used with the XZING endoscopes, monitor and other peripheral device for endoscopic observation, diagnosis and treatment.

Source page: https://510kreport.com/device/K192704
Methodology: https://510kreport.com/methodology