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    K Number
    K050454
    Device Name
    OMNITECH FULGURATING ELECTRODE
    Manufacturer
    OMNITECH SYSTEMS, INC.
    Date Cleared
    2005-05-27

    (94 days)

    Product Code
    FAS
    Regulation Number
    876.4300
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    OMNITECH FULGURATING ELECTRODE

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

    The Omnitech Fulgurating Electrode Device is indicated for the resection/coagulation of the soft tissue and is intended for the use with compatible Cystoscopes and Ureteroscopes. The device will be sold as a sterile product to be used in the Urological field.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a medical device called the "Omnitech Fulgurating Electrode." It certifies that the device is substantially equivalent to legally marketed predicate devices.

    The provided text does NOT contain information about acceptance criteria or a study proving that the device meets those criteria.

    This document is a regulatory approval, not a performance study report. Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.

    The document only states the device's indications for use:
    "The Omnitech Fulgurating Electrode Device is indicated for the resection/coagulation of the soft tissue and is intended for the use with compatible Cystoscopes and Ureteroscopes. The device will be sold as a sterile product to be used in the Urological field."

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