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510(k) Data Aggregation

    K Number
    K241913
    Device Name
    da Vinci Handheld Camera
    Manufacturer
    Intuitive Surgical Operations, Inc.
    Date Cleared
    2024-08-28

    (58 days)

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

    Intuitive Surgical Operations, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The da Vinci Handheld Camera is intended for endoscopic viewing of internal surgery sites during minimally invasive surgery. It is designed for use with compatible da Vinci Surgical Systems.
    Device Description
    The da Vinci Handheld Camera is a lightweight handheld 2D Camera which can be connected to any third party 5 mm to 10 mm laparoscope to view images on the compatible da Vinci System Vision cart. The da Vinci Handheld Camera consists of the camera head, the light guide, and the light guide adapter. The da Vinci Handheld Camera Light Guide is a detachable device that connects to the third party laparoscope via a Handheld Camera Light Guide Adapter and to the da Camera comector prior to connecting it to the Endoscope controlle da Vinci Surgical System. The camera is reusable and is not provided sterile to the users. The da Vinci Handheld Camera connects to a compatible da Vinci Surgical System Vision Cartroller. The da Vinci Handheld Camera. Light Guide and Light Guide Adapter are designed first entry and laparoscopic tasks during robotic procedures, prior to docking the compatible da Vinci Surgical System patient cart. It is intended to be used by surgeons, circulating nurses (non-sterile user) and scrub nurses (sterile user), in a hospital operating room (OR).
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