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510(k) Data Aggregation

    K Number
    K120268
    Device Name
    AMID STAPLER
    Manufacturer
    SAFESTICH MEDICAL, LLC
    Date Cleared
    2012-02-10

    (11 days)

    Product Code
    GDWGAG
    Regulation Number
    878.4750
    Why did this record match?
    Applicant Name (Manufacturer) :

    SAFESTICH MEDICAL, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The SafeStitch AMID Stapler® has application in general surgery procedures for fixation of mesh, in the repair of hernia defects and in other surgical specialties for the approximation of tissue(s), including skin.
    Device Description
    The SafeStitch AMID Stapler™ contains 17 titanium staples. The AMID Stapler™ places a staple each time the instrument's handle is squeezed. The staple legs first penetrate the tissue or mesh and then fully form, thus anchoring or approximating the tissue(s) and/or mesh.
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