K252176

Single-Use Video Flexible Cysto-Nephroscope (RP-U-C01F, RP-U-C01FS)

510(k) number: K252176
Device name: 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: 2025-08-08
Date received: 2025-07-11
Decision: Substantially Equivalent
Clearance type: Special
Advisory committee: Gastroenterology, Urology

Also available from FDA: K252176.pdf

Official FDA record: K252176

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