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510(k) Data Aggregation

    K Number
    K071756
    Device Name
    ENDOHUB- 1.0 ENDOSCOPIC VIDEO CAMERA SYSTEM WITH VIDEO CAPTURE
    Manufacturer
    POINTE CONCEPTION MEDICAL, INC
    Date Cleared
    2007-08-15

    (48 days)

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

    POINTE CONCEPTION MEDICAL, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Endohub-1.0 Endoscopic Video Camera with Video Capture is intended to be used as an endoscopic video camera in a variety of endoscopic surgical procedures, including but not limited to; orthopedic, laparoscopic, urologic, sinuscopic and plastic surgical procedures. The device is also intended to be used as an accessory for microscopic surgery.
    Device Description
    The Endohub-1.0 Endoscopic Video Camera System is a video camera system which consists of a Camera Control Unit [CCU] and Camera Head. The Endohub-1.0 Camera System is used in conjunction with an endoscope to allow for visualization during minimally invasive surgical procedures. Sterilization of the camera head may be required prior to use. The camera head may be steam sterilized. The camera head may utilize 1CCD or 3CCD image sensors, and employ either fixed or variable focal length optics. The Endohub-1.0 Camera System incorporates an image capture system which allows for the capture of streaming video or still video images.
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