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Single-Use Video Flexible Ureterorenoscope System

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K221158

by Guangzhou Red Pine Medical Instrument Co., Ltd.

Identifiers

510(k) Number
K221158 FDA 510(k)
FDA Product Code
FGB FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 876.1500 FDA 510(k)
Regulation Number
876.1500 FDA 510(k)
Advisory Committee
Gastroenterology, Urology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

This device is a single-use video flexible ureterorenoscope, classified as a flexible/rigid ureteroscope and accessories. It combines an endoscopic camera system with a flexible insertion tube to visualize and access the urinary tract, particularly the ureters and renal pelvis, for diagnostic and therapeutic procedures in urology and gastroenterology.

The system includes a sterile, disposable ureterorenoscope (handle and insertion portion) and an endoscopic video image processor with accessories such as a touchscreen PC, power adapter, and footswitch. Supplied sterile and intended for single-use, it is regulated under FDA 510(k) clearance (K221158) and the EU Medical Device Regulation (MDR). The device is designed for use in clinical settings requiring minimally invasive procedures, with no indication of MRI compatibility or reusable components.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Guangzhou Red Pine Medical Instrument Co.,Ltd., Single-Use Video Flexible Ureterorenoscope System (K221158) — FDA 510 ..., PDF Guangzhou Red Pine Medical Instrument Co., Ltd. Regulatory Affairs ...

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Guangzhou Red Pine Medical Instrument Co., Ltd.

Sources (2)

  • FDA 510(k) K221158 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 18, 2026