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510(k) Data Aggregation

    K Number
    K962032
    Device Name
    KARL STORZ TWIN TRANSILLUMINATOR
    Manufacturer
    KARL STORZ ENDOSCOPY-AMERICA, INC.
    Date Cleared
    1996-07-05

    (42 days)

    Product Code
    MQW
    Regulation Number
    874.4350
    Type
    Traditional
    Panel
    Ear Nose & Throat
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Product Code :

    MQW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Karl Storz Universal Twin Transilluminator and Universal Fiber Optic Twin Transilluminator are designed to transilluminate sinus tissue during ENT procedures.

    Device Description

    The Karl Storz Universal Twin Transilluminator and Universal Fiber Optic Twin Transilluminator are manual, reusable, nonsterile medical devices. The body contact materials of these devices have a long history of biocompatibility with medical devices.

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) summary for a medical device called "Karl Storz Universal Twin Transilluminator". This document describes the device, its intended use, and claims substantial equivalence to predicate devices.

    However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or any other details related to a performance study as requested in your prompt.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the given input.

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