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510(k) Data Aggregation

    K Number
    K241502
    Device Name
    P-SCOPE
    Manufacturer
    Date Cleared
    2024-07-24

    (57 days)

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

    OUI Medical Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    P-Scope is intended to be used in diagnostic and therapeutic procedures for endoscopy within the peritoneal cavities including the female reproductive organs.
    Device Description
    The device contains two separate functioning components. First is the single-use, sterile P-scope device, which includes camera mounted on a 3 or 5 mm rigid shaft and reusable high-definition video display includes ports such as USB and HDMI, which allow for connections to external high-definition video screens. This feature enables the surger and more detailed view of the surgical field during the procedure. In summary, the P-scope combines the single-use laparoscope device with a high-definition video camera for imaging, and a reusable video display with an image processor for displaying the video feed, along with connectivity options to external video screens.
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