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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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    K Number
    K213914
    Device Name
    Injection Needle
    Manufacturer
    Jiangsu Vedkang Medical Science and Technology Co.,Ltd
    Date Cleared
    2022-07-29

    (226 days)

    Product Code
    FBK
    Regulation Number
    876.1500
    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 device is intended to be used with an endoscope to perform endoscopic vascular or submucosal injection in the GI tract.
    Device Description
    The injection needle is intended to be used with an endoscope to perform endoscopic vascular or submucosal injection in the GI tract, which consists of needle, connector tube, outer tube, outer tube, outer tube, protective sleeve, front handle, injection handle, front handle cover and boosting tube. The proposed device is used to puncture the target tissue where guided by the endoscope. The fluid is injected to the target through the proposed device by an injector which is connected the proposed device.
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