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510(k) Data Aggregation

    K Number
    K981464
    Device Name
    OMNITECH RESECTOSCOPE CUTTING LOOP ELECTRODE
    Manufacturer
    OMNITECH SYSTEMS, INC.
    Date Cleared
    1998-07-10

    (78 days)

    Product Code
    KNF
    Regulation Number
    884.4160
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    N/A
    Predicate For
    K070315
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Omnitech Resectoscope Cutting Loop Electrode Device is indicated for resection/ coagulation of the soft tissue and is intended for the use with compatible resection/ The device will be sold as a sterile product to be used in the Urological and Gynecological fields.

    Device Description

    Omnitech Resectoscope Cutting Loop Electrode

    AI/ML Overview

    I am sorry, but the provided text does not contain the information needed to answer your request. The document is an FDA 510(k) clearance letter for a "Resectoscope Cutting Loop Electrode" and primarily focuses on regulatory approval. It does not include details about device performance acceptance criteria, study methodologies, or AI/software validation.

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