Pusen Single Use Flexible Video Cystoscope System (Single Use Flexible Video Cystoscope: PC200-AS, PC200-AR, PC200-S and PC200-R; HD Medical Video Endoscope Image Processor: PV300)— 510(k) K222602

Substantially Equivalent

Zhuhai Pusen Medical Technology Co., Ltd.

FDA 510(k) clearance K222602 for Pusen Single Use Flexible Video Cystoscope System (Single Use Flexible Video Cystoscope: PC200-AS, PC200-AR, PC200-S and PC200-R; HD Medical Video Endoscope Image Processor: PV300), Substantially Equivalent on 2022-09-26. Applicant: Zhuhai Pusen Medical Technology Co., Ltd..

Clearance details

Applicant: Zhuhai Pusen Medical Technology Co., Ltd.
Product code: Code FAJ
Advisory panel: Gastroenterology, Urology
Date received: 2022-08-29
Decision date: 2022-09-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Zhuhai, 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.