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

    KARL STORZ UNIPOLAR BALL, NEEDLE, LOOP ELECTRODES

    K Number: K944795 · Decision Dec 21, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    67
    Registration Numbers
    67
    Same Product Code
    56
    Applicant Total
    318
    Review Days
    84

    Basic Information

    Device Name
    KARL STORZ UNIPOLAR BALL, NEEDLE, LOOP ELECTRODES
    K Number
    K944795
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.4300
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    KARL STORZ ENDOSCOPY-AMERICA, INC.
    Date Received
    September 28, 1994
    Decision Date
    December 21, 1994
    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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