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    K Number
    K081766
    Device Name
    PKS OMNI INSTRUMENT
    Manufacturer
    GYRUS-ACMI L.P.
    Date Cleared
    2008-08-08

    (49 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    GYRUS-ACMI L.P.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Gyrus ACMI Inc. PKS Omni Instrument is intended for electrosurgical coagulation, mechanical grasping, and dissection of tissue, and sealing of vessels up to 3mm, during the performance of laparoscopic and general (open) surgical procedures when used in conjunction with the Gyrus ACMI G400 workstation.
    Device Description
    The PKS Omni Instrument is a single-use device with a classic laparoscopic so layout, with a 5mm shaft available in several lengths from 15 to 45cm, supporting symmetrically opening steel jaws. These are curved in a manner similar to Maryland forceps and other laparoscopic graspers, and contain bipolar electrosurgical elements that allow coagulation, cutting and vessel sealing. It is intended for use with the Gyrus ACMI G400 workstation
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