K252468
- 510(k) number
- K252468
- Device name
- Single-use Digital Flexible Ureteroscope (GY-UR9.3); Single-use Digital Flexible Ureteroscope (GY-UR8.4); Single-use Digital Flexible Ureteroscope (GY-UR7.5); Endoscope camera system (GY-AIO-121)
- Applicant
- Zhejiang Geyi Medical Instrument Co., Ltd. CN
- Product code
- FGB — Ureteroscope And Accessories, Flexible/Rigid
- Decision date
- 2025-12-16
- Date received
- 2025-08-06
- 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: K252468.pdf
Official FDA record: K252468
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.