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510(k) Data Aggregation

    K Number
    K173919
    Device Name
    HX Device
    Manufacturer
    Human Extension Ltd.
    Date Cleared
    2018-03-20

    (88 days)

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

    Human Extension Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The HX Device is intended to assist in the accurate control of HX laparoscopic Instruments including needle holder and grasper, for endoscopic manipulation of tissue, including grasping, approximation, ligation, suturing, during laparoscopic surgical procedures. It is intended to be used by trained physicians in an operating room environment in accordance with its Instructions For Use.
    Device Description
    The Human Extensions HX Device is a hand held powered laparoscopic device. The device enables, by its attached instruments grasper and needle holder, the surgeon to perform a variety of minimally invasive surgeries. As the device is controlled by the surgeon's hand, it acts as a "surgeon's hand extension", enhancing maneuverability and control. The HX Device is electromechanically controlled and includes both hardware and software and comprises of two major parts, the Handpiece and the Instrument. The HX Device Handpiece consists of a reusable Control Interface (CI) handle held by the surgeon and a Handpiece Body that translates the surgeon's maneuvers and movements of their hands by means of control buttons to the instrument-articulating tip (grasper/needle holder). Prior to use, a set of single use, disposable, sterile Power Cable, Arc, Finger Pads, and strap-adapting Spacer are assembled on the Handpiece and the CI unit. In addition, prior to use, the Handpiece is covered with a standard, sterile cover (e.g., endoscopic camera cover) of at least 8.5 cm inner diameter. The sterile cover is not provided with the HX device. After each use, the Handpiece is cleaned and disinfected according to the specifications detailed in the Instructions For Use.
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