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510(k) Data Aggregation

    K Number
    K122820
    Device Name
    VIKY UP
    Manufacturer
    Date Cleared
    2013-06-18

    (277 days)

    Product Code
    Regulation Number
    884.4530
    Why did this record match?
    Applicant Name (Manufacturer) :

    ENDOCONTROL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The ViKY UP device is indicated for computer-controlled laparoscopic hysterectomies (such as da Vinci-assisted laparoscopic hysterectomies) for the purpose of holding and controlling the movement of a uterine manipulator.
    Device Description
    ViKY UP is a motorized uterine manipulator positioner for computer-controlled laparoscopic hysterectomies. ViKY UP holds and moves the uterine manipulator in three directions according to surgeon orders by means of either a foot controller or a voice controller. Use of the ViKY UP allows surgeon to remotely gain control on uterine manipulator positioning from his operating position. The ViKY UP includes two attachment mechanisms: one at its first end for mounting the system to the operating room table and the other at the second end for securely grasping a uterine manipulator. The ViKY UP remains external to the patient's body at all times and can be steam sterilized.
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    K Number
    K082233
    Device Name
    VIKY
    Manufacturer
    Date Cleared
    2008-12-18

    (133 days)

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

    ENDOCONTROL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The ViKY System is a motorized device whose intended use is to allow a surgeon to hold and position a rigid endoscope during endoscopic surgical procedures. Its light architecture allows the ViKY System to be maintained above the patient by a dedicated arm attached to the table. The ViKY System movements are controlled by the surgeon either by a foot controller or a voice controller. The ViKY System is indicated for thoracic and laparoscopic minimally invasive procedures for the purpose of holding and controlling the movement of standard rigid endoscopes within surgical cavities during endoscopic surgery.
    Device Description
    ViKY is a motorized endoscope holder for thoracic, abdominal, and pelvic minimally invasive procedures. ViKY is maintained by a dedicated arm attached to the table. It is moved according to surgeon orders by means of either a foot controller or a voice controller, in caudal, cranial and lateral directions, as well as zoom in and zoom out of the field.
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