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510(k) Data Aggregation

    K Number
    K251951

    Validate with FDA (Live)

    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)
    Manufacturer
    Guangzhou Red Pine Medical Instrument Co., Ltd.
    Date Cleared
    2025-12-16

    (174 days)

    Product Code
    FGB
    Regulation Number
    876.1500
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Age Range
    All
    Reference & Predicate Devices
    K241500,K243321,K221158
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The device has been developed to be used with endoscopic accessories and Endoscopic Video Image Processor for endoscopy and endoscopic surgery within urinary tract and interior of the ureter and kidney.

    Device Description

    The proposed device, Ureterorenoscope System, which includes a Single-Use Video Flexible Ureterorenoscope, an Endoscopic Video Image Processor (model: RP-IPD-V2000EF) which has been cleared under K241500 and an Endoscopic Video Image Processor (model: RP-IPD-V1000F) which has been cleared under K243321 is intended for endoscopy and endoscopic surgery within urinary tract and interior of the ureter and kidney.

    AI/ML Overview

    N/A

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