K251951
- 510(k) number
- K251951
- Device name
- Single-Use Video Flexible Ureterorenoscope (RP-U-C03R9, RP-U-C03R3, RP-U-C03S9, RP-U-C03S3); Endoscopic Video Image Processor (RP-IPD-V2000EF); Endoscopic Video Image Processor (RP-IPD-V1000F)
- Applicant
- Guangzhou Red Pine Medical Instrument Co., Ltd. CN
- Product code
- FGB — Ureteroscope And Accessories, Flexible/Rigid
- Decision date
- 2025-12-16
- Date received
- 2025-06-25
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 2.8 MB · U.S. public domain
Also available from FDA: K251951.pdf
Official FDA record: K251951
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.