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510(k) Data Aggregation

    K Number
    K963166
    Device Name
    O'REGAN LIGATOR
    Manufacturer
    PATRICK J. O'REGAN
    Date Cleared
    1997-05-05

    (264 days)

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

    PATRICK J. O'REGAN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This ligator is intended to be used only as a hemorrhoid ligator.
    Device Description
    The O'Regan, Ligator or Hemorrhoid Ligator is a device for the treatment of hemorrhoids. The technique involves placing elastic bands on tissue in the rectum in the vicinity of the hemorrholds. The bands are placed high enough in the rectum to be above the sensitive area so that any discomfort from the procedure is minimized. The present device provides suction and ligation capability. An elastic band can be stretched over the front end of the ligator by means of the cone shaped loading apparatus. The front end of the ligator is inserted through the anus deep within the rectum. The nozzle is then withdrawn gently as the device is angulated to point directly towards the site to be banded. A mark on the outside of the device will provide a measure as to the level inside the rectum where the band is to be placed. Thus by angling the device acutely in the direction of the tissue to be banded and by measuring the distance from the outside, the band can be placed accurately on the appropriate tissue. The opening at the front end of the device allows only a fairly conservative amount of tissue to be trapped within the chamber and subsequently allow banding of this said amount. This device differs mainly in one respect from other devices available to date. Whereas other devices are designed to be used with the aid of a proctoscope or similar viewing instrument and the band is placed under direct vision, the present device is designed to be used without a proctoscope. The device can be used single handedly, as a proctoscope or an assistant is not necessary to perform the procedure. The device will be made available in a package, labelled clean but not sterile for one time use only. Rubber bands will not be included but are readily available from medical suppliers. The device is made of polypropylene with no colour additive.
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