Single use flexible ureteroscope (UR-D1); Single use flexible ureteroscope (UR-D2); Single use flexible ureteroscope (UR-F1); Single use flexible ureteroscope (UR-F2)— 510(k) K240074

Substantially Equivalent

Shenzhen Besdata Technology Co., Ltd.

FDA 510(k) clearance K240074 for Single use flexible ureteroscope (UR-D1); Single use flexible ureteroscope (UR-D2); Single use flexible ureteroscope (UR-F1); Single use flexible ureteroscope (UR-F2), Substantially Equivalent on 2024-10-04. Applicant: Shenzhen Besdata Technology Co., Ltd..

Clearance details

Applicant: Shenzhen Besdata Technology Co., Ltd.
Product code: Code FGB
Advisory panel: Gastroenterology, Urology
Date received: 2024-01-10
Decision date: 2024-10-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenzhen, 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.