510(k) clearance

Single-Use Video Flexible Ureterorenoscope (RP-U-C06R9, RP-U-C06R3, RP-U-C06S9, RP-U-C06S3)

FDA 510(k) source

510(k) number

K262488

Applicant

Guangzhou Red Pine Medical Instrument Co., Ltd.

Decision date

Sep 9, 2026

Date received

Jul 20, 2026

Decision

Substantially Equivalent

Clearance type

Traditional

Product code

FGB

Device type

Ureteroscope And Accessories, Flexible/Rigid

Device class

Class II

Regulation

21 CFR 876.1500

Advisory committee

Gastroenterology, Urology

Statement or summary

Summary

Third party

N

Location

Guangzhou, CN