K241500

Endoscopic Video Image Processor (RP-IPD-V2000EF); Single-Use Video Flexible Cysto-Nephroscope (RP-U-C01F, RP-U-C01FS)

510(k) number
K241500
Device name
Endoscopic Video Image Processor (RP-IPD-V2000EF); Single-Use Video Flexible Cysto-Nephroscope (RP-U-C01F, RP-U-C01FS)
Applicant
Guangzhou Red Pine Medical Instrument Co., Ltd. CN
Product code
FAJ — Cystoscope And Accessories, Flexible/Rigid
Decision date
2024-07-12
Date received
2024-05-28
Decision
Substantially Equivalent
Clearance type
Traditional
Advisory committee
Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain

Also available from FDA: K241500.pdf

Official FDA record: K241500
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.