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    K Number
    K020925
    Device Name
    CARBODISSECTING ENDOSCOPE
    Manufacturer
    ENDO SURGICAL DEVICES, INC.
    Date Cleared
    2003-04-29

    (404 days)

    Product Code
    DWX
    Regulation Number
    870.4875
    Why did this record match?
    Applicant Name (Manufacturer) :

    ENDO SURGICAL DEVICES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Carbodissecting Endoscope is designed for use in intraluminal tissue separation during a femoro-popliteal endarterectomy procedure intended to achieve vascular reconstruction. The device is an adjunctive aid in the separation of vessel layers.
    Device Description
    The Carbodissecting Endoscope, sterile and single-use, consists of two components: The spatula is a surgical tool used with carbon dioxide (CO2) and saline for atherectomy using carbodissection. The scope is a flexible fiberscope intended for use with the Carbodissecting Endoscope Spatula to provide visual feedback.
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    K Number
    K013680
    Device Name
    CARBODISSECTING ENDOSCOPE
    Manufacturer
    ENDO SURGICAL DEVICES, INC.
    Date Cleared
    2002-03-04

    (117 days)

    Product Code
    GEI, GCJ
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    ENDO SURGICAL DEVICES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To gently dissect planes of soft tissue using controlled bursts of CO2 gas. The device may be used in both open and endoscopic procedures in which gentle, blunt dissection of soft tissue planes is desired.
    Device Description
    The Carbodissecting Endoscope consists of two components: The Spatula is a surgical tool used in combination with CO2 and saline, and is designed to be used with the supplied Scope to provide accurate visual feedback during a carbodissection procedure. The tip allows the surgeon to slide between the tissue planes. The front of the tip is slightly curved and has multiple CO2 outlets. The multiple CO2 outlets are used to fan the gas out along the entire front of the tip to help peel apart the two layers, to aid in the separation of the tissue The Scope is a flexible fiberscope intended for use with the Spatula.
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