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

    VIVAWAVE MICROWAVE SYSTEM

    K Number: K011676 · Decision Jun 18, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    38
    Registration Numbers
    38
    Same Product Code
    67
    Applicant Total
    10
    Review Days
    384

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    Basic Information

    Device Name
    VIVAWAVE MICROWAVE SYSTEM
    K Number
    K011676
    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
    Vivant Medical, Inc.
    Date Received
    May 30, 2001
    Decision Date
    June 18, 2002
    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

    Similar 510(k) Clearances

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    Other Clearances by Vivant Medical, Inc.

    K Number Device Name
    K050223 VIVAWAVE MICROWAVE ABLATION SYSTEM, COAXIAL INTRODUCER
    K040279 VIVARING MICROWAVE ABLATION PROBE
    K032702 VIVATIP MICROWAVE ABLATION PROBE
    K032047 TRI-LOOP MICROWAVE ABLATION PROBE
    K031556 VIVATHERM THEMPERATURE MEASUREMENT SYSTEM
    K023311 LOOP MICROWAVE ABLATION PROBE
    K022286 ENCIRCLE LOCALIZATION DEVICE
    K003439 VIVANT BREAST LESION LOCALIZATION DEVICE
    K000278 VIVANT MEDICAL BIOPSY MARKER SYSTEM