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510(k) Data Aggregation

    K Number
    K020526
    Device Name
    MODIFICATION TO WILSON-COOK MULTIPLE BAND LIGATOR
    Manufacturer
    DON WILSON/WILSON-COOK MEDICAL, INC.
    Date Cleared
    2002-03-19

    (28 days)

    Product Code
    FHN
    Regulation Number
    876.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    DON WILSON/WILSON-COOK MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Used to ligate internal hemorrhoids.
    Device Description
    The Wilson-Cook Modified Multiple Band Ligator is used to ligate internal hemorrhoids. This device is supplied non-sterile and intended for single use only. The modification of the predicate Wilson-Cook Multiple Band Ligator (K944220/A) consists of a change to the handle in order to accommodate single-hand operation through an anoscope. In addition, the modified device comes preloaded with the barrel attached to the tip of the handle. The predicate device is designed for attachment to the end of an endoscope, while the modified Multiple Band Ligator is used in conjunction with an anoscope. The barrel and bands of the modified device are identical to the barrel and bands of the Wilson-Cook Multiple Band Ligator in the choice of the production and the specifications of each. The trigger cord is comprised of the same materials, however the trigger cord is slightly shorter in length for the modified devices, as the modified device comes preloaded and is used with an anoscope. Loading catheter and irrigation adapter are not needed.
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