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510(k) Data Aggregation

    K Number
    K252468

    Validate with FDA (Live)

    Device Name
    Single-use Digital Flexible Ureteroscope (GY-UR9.3); Single-use Digital Flexible Ureteroscope (GY-UR8.4); Single-use Digital Flexible Ureteroscope (GY-UR7.5); Endoscope camera system (GY-AIO-121)
    Manufacturer
    Zhejiang Geyi Medical Instrument Co., Ltd.
    Date Cleared
    2025-12-16

    (132 days)

    Product Code
    FGB
    Regulation Number
    876.1500
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Age Range
    All
    Reference & Predicate Devices
    K172098
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Single-use Digital Flexible Ureteroscope is intended to be used to visualize organs, cavities and canals in the urinary tract (urethra, bladder, ureter, calyces and renal papillae) via transurethral access routes. It can also be used in conjunction with endoscopic accessories to perform various diagnostic and therapeutic procedures in the urinary tract.

    Device Description

    The Single-Use Digital Flexible Ureteroscope system consists of Single-Use Digital Flexible Ureteroscope and Endoscope camera system.

    Single-Use Digital Flexible Ureteroscope consists of a distal tip, a bending part, an insertion part, an operating part and an electrical connection part. The tip is integrated with LED lighting source, 160,000 pixel CMOS image sensor and instrument channel tube with inner diameter of 1.2mm or 1.1mm. During use, LED light source provides illumination, CMOS image sensor is used to collect image pixels of tissue parts, and instrument channel tube is used as the use channel of stone basket, holmium laser fiber, etc. Under the upper and lower 45° swing operation of the control knob, the upper and lower 275° swing angle of the deflection section can be realized. The operating handle is equipped with two functional shortcut keys, which have corresponding functions preset with the endoscope camera host. The Single-Use Digital Flexible Ureteroscope is powered by the Endoscope camera system. The electrical connection part transmits the image pixels obtained from the image sensor to the host, thus realizing the function of surgical imaging. The Endoscope camera system receives a video signal from a connected endoscope, controls the light from the tip of the endoscope and outputs that signal, including a graphical user interface, while presenting the image to the user.

    Endoscope camera system consists of a portable image processor generator, Power flexible cable (1.5m) x1, Power adapter (cable 1.0m)x1, HDMI cable (2.0m)x1.

    The Single-Use Digital Flexible Ureteroscope is provided sterile (sterilized by EO) and intended to be single-use. The Endoscope camera system is a reusable multi-patient use device.

    AI/ML Overview

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