BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    ACCULIS ACCU21 PMTA MICROWAVE TISSUE ABLATION APPLICATOR

    K Number: K122762 · Decision Nov 30, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    38
    Registration Numbers
    38
    Same Product Code
    67
    Applicant Total
    2
    Review Days
    81

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    Basic Information

    Device Name
    ACCULIS ACCU21 PMTA MICROWAVE TISSUE ABLATION APPLICATOR
    K Number
    K122762
    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
    Microsulis Medical Limited
    Date Received
    September 10, 2012
    Decision Date
    November 30, 2012
    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 Microsulis Medical Limited

    K Number Device Name
    K094021 ACCULIS ACCU2I PMTA APPLICATOR MODEL ACCU2I