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510(k) Data Aggregation

    K Number
    K252598
    Date Cleared
    2025-09-15

    (28 days)

    Product Code
    Regulation Number
    876.1500
    Reference & Predicate Devices
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K243497

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    AnQing Medical Single Use Flexible Cystoscope is used to provide visualization and operative access during diagnostic and therapeutic endoscopic procedures of the lower urinary tract, including the bladder and urethra.

    The Flexible Cystoscope is intended for use in a hospital environment or medical office environment.

    The Flexible Cystoscope is designed for use in adults.

    Device Description

    The Flexible Cystoscope (Model: CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US) is a sterile single-use endoscope which is used with the video processor cleared via K243497 for providing endoscopic imaging of the lower urinary tract, including the bladder and urethra for the purpose of diagnosis and treatment.

    The CY50H-20 and CY55H-24 difference is the size of Distal End Outer Diameter and Working Channel Inner Diameter. The US and EU model are identical except the deflection versions, which is opposite from each other (EU version or US version).

    The Flexible Cystoscope is a single-use endoscope, which consists of Handle, Insertion Section, Distal Tip, and Endoscope Connector. The handle includes a deflection lever, a lever lock, a push button for picture taking/video recording and a Luer port for insertion of accessory devices and irrigation to the working channel. The insertion section contains one working channel and wiring to transmit the image signals to the video processor. The distal bending section of the insertion section is controlled by the user via the deflection lever on the handle. The distal end of the insertion section contains a CMOS sensor for capturing image and transmitting it to the video processor, LEDs for illumination, and the distal opening of the working channel. The endoscope connector connects the endoscope handle to the video processor, which provides power and processes video signals from the endoscope.

    Mechanism of action:
    The light emitted by the LED cold light source at the distal tip of the disposable Flexible Cystoscope is irradiated into the body cavity, and the light reflected from the cavity enters the optical system and is captured by the CMOS image sensor. The CMOS acquisition image is controlled by the CMOS drive circuit, and the RGB video signal is output to the video processor. The video processor receives video signals from the endoscope, processes the video signals, and outputs the processed video signal to the built-in screen or attached external monitor. The video processor also controls the brightness of the LEDs on the endoscope.

    Flexible Cystoscope has the following physical and performance characteristics:

    • Maneuverable tip controlled by the user
    • Flexible insertion cord
    • Camera and LED light source at the distal tip
    • Sterilized by Ethylene Oxide
    • For single use
    AI/ML Overview

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