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510(k) Data Aggregation

    K Number
    K981598
    Device Name
    HERNIA MESH STABILIZER
    Manufacturer
    MEDIVICES CO.
    Date Cleared
    1998-07-01

    (58 days)

    Product Code
    GCJ
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDIVICES CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Temporary mesh fixation to the inner surface of the abdominal wall to facilitate the permanent placement, by stapling, of the mesh when used in the standard fixation technique for Laparoscopic Hernia Repair.
    Device Description
    Stylet with 16 gauge Cannula, for insertion through a separate incision into the abdominal cavity, in Laparoscopic Hernia Repair, to capture and temporarily hold. with spring retraction, the surgical mesh against the abdominal wall for permanent attachment by stapling. On completion of stapling, the stylet and cannula are advanced to release the mesh, enclose the hook within the cannula and safely remove the Hernia Mesh Stabilizer from the surgical site.
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