Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K032238
    Device Name
    TWISTER SUPERELASTIC LIGATING CLIP AND APPLIER
    Date Cleared
    2003-09-09

    (50 days)

    Product Code
    Regulation Number
    878.4300
    Why did this record match?
    Applicant Name (Manufacturer) :

    NEUROSEL (MEDICAL) LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Twister™ Superelastic Ligating Clip, Size M, and its applier is intended for the permanent occlusion or ligation of blood vessels and other tubular body structures, wherever a metal ligating clip is indicated, and within the size range of 2.0 to 3.5mm diameter.
    Device Description
    The Twister" Superelastic Ligating Clip System comprises a dedicated applier containing a number of Twister™ Superelastic Ligating Clips held in-train in an unstretched state. The applier consists of a front nozzle, handle and main body with a trigger. The clips are applied by a two stage trigger activation process of the applier; in the first step the clip is advanced and stretched to an open position, and in the second step the clip is released into position on the vessel or structure to be ligated. Prior to activation, the applier nozzle design allows for assessment of the suitability of a particular clip size in relation to that of the blood vessel, or other body tubular structure. Surgeons should only apply an appropriately sized clip for the size of vessel or tissue structure to be ligated, such that the clip completely encompasses the vessel or tissue structure. The specific nozzle design is intended to assist the surgeon in optimal clip application, by virtue of its shape and external guide markings. The Twister™ clip is manufactured from a Superelastic Nitinol alloy, which has a shape memory effect. During application of the Twister™ clip, the clip is opened for placing over the vessel or structure. On its release from the applier, the Twister™ clip resumes its original 'shape memory' closed position, and its arms encircle the vessel or structure - effectively ligating the vessel or structure by applying a pressure. The Twister™ clip and its applier are single use medical devices and both the applier and any remaining unused clips should be discarded following the surgical procedure The Twister applier and clips are not intended for re-sterilization.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1