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510(k) Data Aggregation

    K Number
    K973249
    Device Name
    ENDOASSIST
    Manufacturer
    ARMSTRONG HEALTHCARE LTD.
    Date Cleared
    1997-11-26

    (89 days)

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

    ARMSTRONG HEALTHCARE LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Endo Assist positions a Laparescope, and is indicated for use laparoxopic, thoracoscopic and pelvic procedures. Laparoscopic: cholecystectory hernia repair Fundaplication Splenectomy appendectiony henicolectory synpathe ctony by oph node dissection hysterectory nysterectomy
    Device Description
    EndoAssist is a microprocessor-driven robotic arm which holds a rigid laparoscope for the surgeon during laparoscopic surgical procedures. It stands separately from the operating table, and reaches up and over into the surgical field through a series of motorized mechanical linkages. These motors allow the microprocessor to change the configuration of the linkage.
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