Endofresh Digestive Endoscopy System— 510(k) K192704

Substantially Equivalent

Huizhou Xzing Technology Co., Ltd.

FDA 510(k) clearance K192704 for Endofresh Digestive Endoscopy System, Substantially Equivalent on 2020-09-02. Applicant: Huizhou Xzing Technology Co., Ltd..

Clearance details

Applicant: Huizhou Xzing Technology Co., Ltd.
Product code: Code FDS
Advisory panel: Gastroenterology, Urology
Date received: 2019-09-27
Decision date: 2020-09-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Huizhou, CN

Download summary PDF View on FDA.gov ↗

Adverse events under product code FDS

product code FDS

Death: 37
Injury: 863
Malfunction: 56,442
Other: 1
Total: 57,343

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.