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510(k) Data Aggregation

    K Number
    K110355
    Device Name
    VENX REVOLUTION
    Manufacturer
    VENX LLC
    Date Cleared
    2011-04-22

    (74 days)

    Product Code
    GAH
    Regulation Number
    878.4800
    Why did this record match?
    Applicant Name (Manufacturer) :

    VENX LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The VENX REVOLUTION™ is a manual surgical instrument intended for use in the destruction of spider veins in the lower extremities of the body.
    Device Description
    The VENX REVOLUTION™ is a sterile, disposable, single patient use surgical instrument for the disruption and destruction of spider veins located in the lower extremities of the body. The device is made available in several sizes to accommodate a range of veins that form in the lower body. The VENX REVOLUTION™ consists of a thermoplastic handle containing a lever actuated rack and gear mechanism for rotating a shaft extending from the handle. At the end of the shaft are stainless steel, needle-like tines sharpened and spaced appropriately to straddle veins located just below the surface of the skin. Once the tines are in place straddling the vein, the levers are actuated causing the shaft to rotate approximately 360° or more. Actuating the levers causes internal springs to compress. Once the levers have rotated the shaft 360° and the tines have disrupted the vein, releasing the levers allows the compressed springs to return the tines to their original position. The device is then withdrawn and re-inserted at another position within the clinician-selected area to repeat the operation on the same vein or on another vein. The procedure is repeated until all veins within the selected area have been treated.
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