BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    OMNITECH RESECTOSCOPE ROLLER ELECTRODE

    K Number: K965093 · Decision Mar 19, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    67
    Registration Numbers
    67
    Same Product Code
    57
    Applicant Total
    6
    Review Days
    90

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    Basic Information

    Device Name
    OMNITECH RESECTOSCOPE ROLLER ELECTRODE
    K Number
    K965093
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.4300
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Omnitech Systems, Inc.
    Date Received
    December 19, 1996
    Decision Date
    March 19, 1997
    Product Code
    FAS
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    FAS Electrode, Electrosurgical, Active, Urological

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    Other Clearances by Omnitech Systems, Inc.

    K Number Device Name
    K151976 Omnitech HF Resection Electrodes, Omnitech HF Vaporization Electrode
    K050454 OMNITECH FULGURATING ELECTRODE
    K981463 OMNITECH RESECTOSCOPE ROLLER ELECTRODE
    K981464 OMNITECH RESECTOSCOPE CUTTING LOOP ELECTRODE
    K964365 RESECTOSCOPE CUTTING LOOP ELECTRODE