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510(k) Data Aggregation

    K Number
    K130489
    Device Name
    ELECTRODE, FLEXIBLE SUCTION COAGULATOR
    Manufacturer
    OPTIM, LLC.
    Date Cleared
    2013-04-19

    (53 days)

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

    OPTIM, LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PRECISION Endoscopic Infrared Coagulator with single-use disposable MAXiguide flexible light guide is intended for treatment of hemorrhoids and other lesions in the colon and rectum by the transmission of infrared energy when used as an accessory to a colonoscope, flexible sigmoidoscope, or other flexible gastrointestinal endoscope.
    Device Description
    This device is designed to coagulate blood and tissue, specifically for treatment of hemorrhoids and small lesions in the colon and rectum, when used as an accessory to a flexible endoscope.
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