HJY VisualNext Endoscopic Vision System— 510(k) K222735

Substantially Equivalent

Hjy Smart Medical Device Co., Ltd.

FDA 510(k) clearance K222735 for HJY VisualNext Endoscopic Vision System, Substantially Equivalent on 2023-07-28. Applicant: Hjy Smart Medical Device Co., Ltd..

Clearance details

Applicant: Hjy Smart Medical Device Co., Ltd.
Product code: Code GWG
Advisory panel: Neurology
Date received: 2022-09-09
Decision date: 2023-07-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taipei City, TW

Download summary PDF View on FDA.gov ↗

Adverse events under product code GWG

product code GWG

Death: 5
Total: 5

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.