Flexible Ureterorenoscope (Model: US31E-12-EU, US31E-12-US)— 510(k) K222737

Substantially Equivalent

Shanghai AnQing Medical Instrument Co., Ltd.

FDA 510(k) clearance K222737 for Flexible Ureterorenoscope (Model: US31E-12-EU, US31E-12-US), Substantially Equivalent on 2022-10-05. Applicant: Shanghai AnQing Medical Instrument Co., Ltd..

Clearance details

Applicant: Shanghai AnQing Medical Instrument Co., Ltd.
Product code: Code FGB
Advisory panel: Gastroenterology, Urology
Date received: 2022-09-09
Decision date: 2022-10-05
Decision: Substantially Equivalent
Clearance type: Special
Location: Shanghai, CN

Download summary PDF View on FDA.gov ↗

Adverse events under product code FGB

product code FGB

Death: 6
Injury: 552
Malfunction: 3,922
Other: 1
Total: 4,481

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.