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

    ENDOCARE MONOPOLAR ELECTRODE

    K Number: K965118 · Decision Feb 25, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    67
    Registration Numbers
    67
    Same Product Code
    57
    Applicant Total
    22
    Review Days
    67

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    Basic Information

    Device Name
    ENDOCARE MONOPOLAR ELECTRODE
    K Number
    K965118
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.4300
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Endocare, Inc.
    Date Received
    December 20, 1996
    Decision Date
    February 25, 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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