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510(k) Data Aggregation

    K Number
    K250732
    Device Name
    Disposable Endoscopy Valve Set
    Manufacturer
    Yangzhou Fartley Medical Instrument Technology Co,. Ltd
    Date Cleared
    2025-06-20

    (101 days)

    Product Code
    ODC
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    Yangzhou Fartley Medical Instrument Technology Co,. Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Disposable Endoscopy Valve Set is a collection of several sterile units. It is intended to be fitted to multiple endoscope working channels/ports to control the flow of fluids, gases and other materials. - Disposable Air/Water Valve: This unit is intended to be fitted to an endoscope air/water channel to control the inflow of medical gases and water, whilst preventing back-flow. - Disposable Suction Valve: This unit is intended to be fitted to an endoscope suction channel to control the operations of suction, whilst preventing inflow of air. - Disposable Biopsy Valve: This unit is intended to be fitted to an endoscope biopsy port to prevent leakage of gases and body fluids during an endoscopic procedure. - Disposable Water Jet Adapter: This unit is designed to prevent backflow and intended to provide irrigation via sterile water supply during GI endoscopic procedures when used in conjunction with an irrigation pump.
    Device Description
    The Disposable Endoscopy Valve Set is a collection of several sterile units. It is intended to be fitted to different endoscopes' working channels/ports to control the flow of fluids, gases and other materials. The sterile units may consist of Disposable Air/Water Valve, Disposable Suction Valve, Disposable Biopsy Valve and Disposable Water Jet Adapter. Disposable Endoscopy Adapter Set may be configured as single valve or multiple valves in any combination up to a maximum of 4 valves.
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