K240074
- 510(k) number
- K240074
- Device name
- Single use flexible ureteroscope (UR-D1); Single use flexible ureteroscope (UR-D2); Single use flexible ureteroscope (UR-F1); Single use flexible ureteroscope (UR-F2)
- Applicant
- Shenzhen Besdata Technology Co., Ltd. CN
- Product code
- FGB — Ureteroscope And Accessories, Flexible/Rigid
- Decision date
- 2024-10-04
- Date received
- 2024-01-10
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K240074.pdf
Official FDA record: K240074
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.