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    K Number
    K080133
    Device Name
    MOUNTABLE ENDOSCOPIC BLADE
    Manufacturer
    A.M. SURGICAL, INC.
    Date Cleared
    2008-03-13

    (55 days)

    Product Code
    EMF
    Regulation Number
    878.4800
    Why did this record match?
    Product Code :

    EMF

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Mountable Endoscopic Blade is indicated for use in minimally invasive ligament or fascia release. - Carpal tunnel release for carpal tunnel syndrome . - Plantar fasciotomy for plantar fasciitis . - Lateral release of the knee for extensor mechanism malalignment . - Forearm fasciotomy for compartment syndrome - . Morton's neuroma for interdigital neuroma - Gastrocnemius release for heel cord contracture (equinus) .
    Device Description
    The Mountable Endoscopic Blade is a device that mounts to a 4mm 30° endoscope.
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    K Number
    K982142
    Device Name
    MOUNTABLE ENDOSCOPIC KNIFE
    Manufacturer
    A.M. SURGICAL, INC.
    Date Cleared
    1998-12-30

    (196 days)

    Product Code
    EMF
    Regulation Number
    878.4800
    Why did this record match?
    Product Code :

    EMF

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    a) Carpal tunnel release / carpal tunnel syndrome b) plantar fasciotomy/ Plantar fascitis c) lateral release of the knee / extensor mechanism malignment d) forearm fasciotomy / compartment syndrome e) Mortons Neuroma/ Interdigital Neuroma
    Device Description
    Mountable Endoscopic Knife
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