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

    MODIFICATION TO MEDWAVES MICROWAVE COAGULATION/ABLATION SYSTEM

    K Number: K083537 · Decision Jan 15, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    38
    Registration Numbers
    38
    Same Product Code
    67
    Applicant Total
    3
    Review Days
    48

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    Basic Information

    Device Name
    MODIFICATION TO MEDWAVES MICROWAVE COAGULATION/ABLATION SYSTEM
    K Number
    K083537
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    878.4400
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medwaves Incorporated
    Date Received
    November 28, 2008
    Decision Date
    January 15, 2009
    Product Code
    NEY
    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
    NEY System, Ablation, Microwave And Accessories

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    Other Clearances by Medwaves Incorporated

    K Number Device Name
    K143203 AveCure Microwave Coagulation-Ablation Generator, AveCure Microwave Large Antenna-Probe, AveCure Microwave Medium Antenna-Probe, AveCure Microwave Small Antenna-Probe, AveCure Microwave Mini Antenna-Probe
    K070356 MEDWAVES MICROWAVE COAGULATION/ABLATION SYSTEM