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

    LARYNGEAL AUGMENTATION IMPLANT

    K Number: K033398 · Decision Dec 12, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    16
    Applicant Total
    4
    Review Days
    49

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    Basic Information

    Device Name
    LARYNGEAL AUGMENTATION IMPLANT
    K Number
    K033398
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.3620
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Bioform, Inc.
    Date Received
    October 24, 2003
    Decision Date
    December 12, 2003
    Product Code
    MIX
    Advisory Committee
    Ear, Nose, Throat
    Review Advisory Committee
    EN
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MIX System, Vocal Cord Medialization

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    Other Clearances by Bioform, Inc.

    K Number Device Name
    K030682 CALCIUM HYDROXYLAPATITE IMPLANT, ICC AND 0.5CC, MODELS 8038-3, 8037-3
    K013243 COAPTITE LARYNGEAL AUGMENTATION SYSTEM 1CC & O.5CC, MODELS 0008021-1, 0008022-1
    K012955 COAPTITE TISSUE MARKER AND COAPTITE FN TISSUE MARKER