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510(k) Data Aggregation

    K Number
    K220089
    Device Name
    Disposable Polyp Snare
    Manufacturer
    Jiangsu Vedkang Medical Science and Technology Co.,Ltd.
    Date Cleared
    2022-09-22

    (254 days)

    Product Code
    FDI, FGX
    Regulation Number
    876.4300
    Why did this record match?
    Applicant Name (Manufacturer) :

    Jiangsu Vedkang Medical Science and Technology Co.,Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Disposable Polyp Snare is intended to be used in combination with endoscope for cutting polyps or other redundant tissues in digestive tract. The snare can be used with or without high-frequency current.
    Device Description
    The subject device is intended to be used in combination with endoscope for cutting polyps or other redundant tissues in digestive tract. The subject device consists of a handle section, a tube section and a loop section. The loop section is inserted into the tube section and is extended and retracted by operating the handle section. The tube section and the loop section are inserted into the gastrointestinal tract through the endoscope. The loop is extended from the tube to resect the target tissue. The resection is performed with or without high-frequency current. The shape of the loop includes oval, crescent, hexagonal, rhombus, dual-width oval, and polygonal. Users can choose the shape of the snare according to their preference and the characteristic of the lesion.
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