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

    SERIES SY DISPOSABLE ELECTROSURGICAL PAD

    K Number: K082204 · Decision Aug 13, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    2
    Applicant Total
    22
    Review Days
    8

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    Basic Information

    Device Name
    SERIES SY DISPOSABLE ELECTROSURGICAL PAD
    K Number
    K082204
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4400
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Ventlab Corp.
    Date Received
    August 5, 2008
    Decision Date
    August 13, 2008
    Product Code
    ODR
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    Y

    Classifications

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

    Product Code Device Name
    ODR Electrosurgical Patient Return Electrode

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