Endofresh Digestive Endoscopy System— 510(k) K192704

Name: FDA 510(k) clearance K192704
Creator: U.S. Food and Drug Administration
Published: 2020-09-02

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.. Device class: 2.

Clearance details

Applicant: Huizhou Xzing Technology Co., Ltd.
Product code: Code FDS
Device class: Class 2
Regulation: 21 CFR 876.1500
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 ↗

Recent devices under product code FDS

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K261400 — Ambu® aScope Gastro; Ambu® aScope Gastro Large2026-09-16
K260824 — Gastrointestinal Videoscope Olympus GIF-2T15002026-08-27
K260856 — Disposable Distal Attachment D-201-134042026-08-27
K253702 — Intuitive Endoluminal Gastrointestinal System (IG1000)2026-08-07
K260573 — EvoEndo Single-Use Endoscopy System2026-04-21

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.