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

    TURBT-RF ELECTRODES AND ELECTROSURGICAL DEVICES

    K Number: K050488 · Decision Apr 1, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    67
    Registration Numbers
    67
    Same Product Code
    57
    Applicant Total
    16
    Review Days
    35

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    Basic Information

    Device Name
    TURBT-RF ELECTRODES AND ELECTROSURGICAL DEVICES
    K Number
    K050488
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.4300
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Prosurg, Inc.
    Date Received
    February 25, 2005
    Decision Date
    April 1, 2005
    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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