InnovexView (GC146-17, GC150-20, GC155-23)— 510(k) K254251

Substantially Equivalent

Shanghai AnQing Medical Instrument Co., Ltd.

FDA 510(k) clearance K254251 for InnovexView (GC146-17, GC150-20, GC155-23), Substantially Equivalent on 2026-02-26. Applicant: Shanghai AnQing Medical Instrument Co., Ltd..

Clearance details

Applicant: Shanghai AnQing Medical Instrument Co., Ltd.
Product code: Code HIH
Advisory panel: Obstetrics/Gynecology
Date received: 2025-12-29
Decision date: 2026-02-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shanghai, CN

Download summary PDF View on FDA.gov ↗

Adverse events under product code HIH

product code HIH

Death: 18
Injury: 973
Malfunction: 5,071
Other: 1
Total: 6,063

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.