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510(k) Data Aggregation

    K Number
    K220884
    Device Name
    Disposable Endoscope Valve Sets
    Manufacturer
    SML Med-Tech Solutions Limited
    Date Cleared
    2023-01-17

    (295 days)

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

    SML Med-Tech Solutions Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Disposable Endoscope Valve Sets 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. It includes an Air/Water Valve, a Suction Valve, a Biopsy Valve and an Auxiliary Water Connector. - 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. - 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. - 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. - Auxiliary Water Connector: This unit is intended to provide irrigation via sterile water supply during GI endoscopic procedures when used in conjunction with an irrigation pump.
    Device Description
    The Disposable Endoscope Valve Sets is a collection of several sterile units, it is intended for single-use and supplied sterile. The subject device is intended to multiple endoscope working channels/ports to control the flow of fluids, gases and other materials. It includes an Air/Water Valve, a Suction Valve, a Biopsy Valve and an Auxiliary Water Connector. - The Suction Valve component of the Disposable Endoscope Valve Sets is designed to be attached to the suction port of the endoscope, allowing the user to aspirate excess fluids or other debris obscuring the endoscopic image. - The Air/Water Valve component of the Disposable Endoscope Valve Sets is designed to be attached to the air/ water port of the endoscope, the activation of the air/ water valve allows the user to control air and water flow to assist in cleansing the lens during procedures. - The Biopsy Valve component of the Disposable Endoscope Valve Sets is intended to cover the endoscope biopsy port during an endoscopy procedure. In addition, the valve provides access for endoscopic device passage and exchange, helps maintain insufflation, and minimizes leakage of biomaterial from the biopsy port throughout the endoscopic procedure. - The Auxiliary Water Connector component of the Disposable Endoscope Valve Sets is designed to be attached to the auxiliary water port of the endoscopes. The auxiliary water connector consists of a backflow valve that prevents the backflow of water or biomaterials from the endoscope to the sterile water bottle.
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