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510(k) Data Aggregation

    K Number
    K153358
    Device Name
    Standard Clamp
    Manufacturer
    STANDARD BARIATRICS
    Date Cleared
    2016-05-02

    (164 days)

    Product Code
    GDJ
    Regulation Number
    878.4800
    Why did this record match?
    Product Code :

    GDJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Standard Clamp is indicated for use in open procedures to grasp, clamp, and manipulate soft tissues.
    Device Description
    The Standard Clamp is a reusable, non-energized, stainless steel surgical instrument. The instrument is comprised of three main sections: handle, shaft, and end effector. The handle is an inline grip with two knobs which are manually rotated in order to manipulate the end effector. The end effector of the clamp is comprised of an upper and lower jaw that close parallel in order to grasp tissue.
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