K243155
- 510(k) number
- K243155
- Device name
- Single-Use Digital Flexible Ureteroscope(F-URS) (ZSR-URS-01, ZSR-URS-02, ZSR-URS-03, ZSR-URS-04)
- Applicant
- Dongguan Zsr Biomedical Technology Company Limited CN
- Product code
- FGB — Ureteroscope And Accessories, Flexible/Rigid
- Decision date
- 2025-02-11
- Date received
- 2024-09-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K243155.pdf
Official FDA record: K243155
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.