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510(k) Data Aggregation

    K Number
    K182664
    Device Name
    FiXcision
    Manufacturer
    Agency for Medical Innovations GmbH
    Date Cleared
    2018-12-07

    (73 days)

    Product Code
    KOA
    Regulation Number
    876.4730
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    Product Code :

    KOA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The A.M.I. FiXcision device is intended to be used by qualified physicians to provide access of internal structures and for manipulating soft tissue (cutting) for treatment of simple anal fistulae.
    Device Description
    FiXcision is an EO-sterilized, single use, multi-part, manual cutting instrument for use during anal fistula surgery in coloproctology. FiXcision enables circumferential tissue removal for the treatment of simple anal fistulae. The four components include the following: - Probe: Component made of stainless steel that passes through the fistula tract. - Guide: Component made of stainless steel that compresses tissue within the fistula tract. - Base Plate: Component made of stainless steel that acts as a stop for the Circular Cutter. - Circular Cutter: Component made of stainless steel and polyvinyl chloride (PVC-U). The Circular Cutter cuts tissue from fistula tract. The distal end of the Circular Cutter has a protective cap made of silicone that is removed prior to use.
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