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510(k) Data Aggregation

    K Number
    K020891
    Device Name
    NAKAO SNARE II AND NAKAO SNARE III
    Manufacturer
    GRANIT MEDICAL INNOVATIONS
    Date Cleared
    2002-06-17

    (90 days)

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

    GRANIT MEDICAL INNOVATIONS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    These devices are intended to endoscopically transect polyps in the gastrointestinal tract (sessile or perdunctuated) using electrocautery. During the same maneuver the polyp is captured, retrieved and submitted for pathological analysis.
    Device Description
    This disposable product consists of a handle equipped with a male plug for connection to a standard ESU, a flexible sheath and a cable to which a snare loop fitted with a net is attached distally. Upon resection, the device and scope is removed from the patient and the polyp removed from the net together in a continuous retrograde motion. The Snare II version is disposed after one use. The Snare III version may be reused with the same patient. The device is available with different loop sizes and the sheath/cable lengths to accommodate different polyp sizes and endoscope types.
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