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510(k) Data Aggregation

    K Number
    K093253
    Device Name
    AMID STAPLER
    Manufacturer
    SAFESTITCH LLC
    Date Cleared
    2009-11-12

    (27 days)

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

    SAFESTITCH LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The SafeStitch LLC AMID Stapler & Non-Absorbable Staples has applications 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 AMID Stapler is a sterile, single use disposable stapler. The AMID Stapler consists of a manual stapler and 17 titanium staplers. It is designed for the stapling of tissue and mesh, specifically for hernia repairs
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