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510(k) Data Aggregation

    K Number
    K211250
    Device Name
    VisionPort System
    Date Cleared
    2021-06-21

    (56 days)

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

    New View Surgical, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The VisionPort System is intended to be used in diagnostic and therapeutic for endoscopic surgery within the thoracic and peritoneal cavities including the female reproductive organs to establish a path of entry for endoscopic instruments and to provide an image of the surgical field. The trocar may be used with or without visualization for primary and secondary insertions.
    Device Description
    The VisionPort System consists of an access port with an integrated camera and light source, the handpiece, a wired control pad to control the camera functions, and a control unit, specifically: - 1. VisionPort System Handpiece single use - HD camera and lighting module a. - b. 12.9mm internal diameter access port with 5-12mm instrument seal - Lens cleaning system (saline wash and wiper blade) C. - d. Connections for saline wash source and insufflation tubing - e. Removable obturator designed for visible entry - 2. VisionPort System Control Pad single use - a. Camera control functions (zoom, pan) - b. Light emitting diode (LED) adjustment - c. Image capture and display control buttons - 3. VisionPort System Control Unit - a. System power - b. Image processing (no patient data recording or retention) - Outputs to operating room monitor(s) and/or third-party Data Control Unit (for image C. capture and printing options)
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