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510(k) Data Aggregation

    K Number
    K090792
    Device Name
    MITAKA UNIARM
    Date Cleared
    2009-07-06

    (104 days)

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

    MITAKA KOHKI CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The UniARM is for use in holding medical devices such as endoscopes and retractors in surgery.
    Device Description
    the Mitaka UniARM-device is for use in holding medical devices in surgery such as neuro endoscopes, general endoscopes, and hand held instruments. It is a balanced device using pneumatic brakes that can be released from a single switch near the endoscope or hand held instrument. Often referred to as a third arm it provides a stable platform to hold an endoscope or hand held instrument allowing the surgeon the use of his two arms. The system can be released by the push of one button and fixes with the release of that button. A second button is depressed by the palm as a safety device.
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