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510(k) Data Aggregation

    K Number
    K120766
    Device Name
    ENDOSCOPIC DIAGNOSTIC & TREATMENT SYSTEM (MODIFICATION)
    Manufacturer
    PROSURG, INC.
    Date Cleared
    2012-09-11

    (182 days)

    Product Code
    FAJ
    Regulation Number
    876.1500
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Predicate For
    K152619
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Prosurg's NeoScope (Cystourethroscope /Cystoureteroscope /Cystonephroscope/ Digital Video System (which includes the Digital video Endoscope and Video Capture Module) is intended for use to examine body cavities, hollow organs and canals in the body, in the Urinary tract, and can be percutaneously to examine the interior of the kidney and using additional accessories can be used to perform various diagnostic and therapeutic procedures.

    The Prosurg's Neoscope (Hysteroscopce) Digital Video System (which includes the Digital Endoscope and Video Capture Module) is intended for use to examine body cavities, hollow organs and canals in the body, in the Gynecological tract, and can be percutaneously to examine the interior of the uterus and using additional accessories can be used to perform various diagnostic and therapeutic procedures.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA to Prosurg, Inc. regarding their NeoScope™ Digital Video Endoscopic System. This document does not contain information about acceptance criteria, device performance studies, or details regarding ground truth establishment, sample sizes, or expert qualifications.

    The letter simply states that the FDA has reviewed the 510(k) and determined the device is substantially equivalent to legally marketed predicate devices, allowing Prosurg, Inc. to market it. It outlines general regulations and compliance requirements but does not include any performance data or study specifics of the kind requested.

    Therefore, I cannot provide the requested table and information based on the input text.

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