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

    CIANNA MEDICAL TISSUE MARKER AND DELIVERY SYSTEM

    K Number: K120804 · Decision Feb 4, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    6
    Applicant Total
    2
    Review Days
    325

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    Basic Information

    Device Name
    CIANNA MEDICAL TISSUE MARKER AND DELIVERY SYSTEM
    K Number
    K120804
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4300
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cianna Medical
    Date Received
    March 16, 2012
    Decision Date
    February 4, 2013
    Product Code
    PBY
    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
    PBY Temporary Tissue Marker

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    Other Clearances by Cianna Medical

    K Number Device Name
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