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

    REPROCESSED ELECTROSURGICAL ELECTRODE

    K Number: K012684 · Decision Jan 18, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    52
    Registration Numbers
    52
    Same Product Code
    35
    Applicant Total
    64
    Review Days
    157

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    Basic Information

    Device Name
    REPROCESSED ELECTROSURGICAL ELECTRODE
    K Number
    K012684
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4400
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sterilmed, Inc.
    Date Received
    August 14, 2001
    Decision Date
    January 18, 2002
    Product Code
    JOS
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    JOS Electrode, Electrosurgical

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