Flexible Cystoscope (CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US)— 510(k) K252598

Substantially Equivalent

Shanghai AnQing Medical Instrument Co., Ltd.

FDA 510(k) clearance K252598 for Flexible Cystoscope (CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US), Substantially Equivalent on 2025-09-15. Applicant: Shanghai AnQing Medical Instrument Co., Ltd..

Clearance details

Applicant: Shanghai AnQing Medical Instrument Co., Ltd.
Product code: Code FAJ
Advisory panel: Gastroenterology, Urology
Date received: 2025-08-18
Decision date: 2025-09-15
Decision: Substantially Equivalent
Clearance type: Special
Location: Shanghai, CN

Download summary PDF View on FDA.gov ↗

Adverse events under product code FAJ

product code FAJ

Injury: 533
Malfunction: 6,705
Total: 7,238

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.