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

    ARAGON SURGICAL RF SYSTEM L2 INSTRUMENT

    K Number: K090306 · Decision Jun 18, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    839
    Registration Numbers
    839
    Same Product Code
    2251
    Applicant Total
    6
    Review Days
    132

    Basic Information

    Device Name
    ARAGON SURGICAL RF SYSTEM L2 INSTRUMENT
    K Number
    K090306
    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
    ARAGON SURGICAL INC.
    Date Received
    February 6, 2009
    Decision Date
    June 18, 2009
    Product Code
    GEI
    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
    GEI Electrosurgical, Cutting & Coagulation & Accessories

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