BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    Vent-Os Sinus Dilation family

    K Number: K160770 · Decision Jun 29, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    223
    Registration Numbers
    223
    Same Product Code
    64
    Applicant Total
    2
    Review Days
    100

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    Basic Information

    Device Name
    Vent-Os Sinus Dilation family
    K Number
    K160770
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    874.4420
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sinusys Corporation
    Date Received
    March 21, 2016
    Decision Date
    June 29, 2016
    Product Code
    LRC
    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
    LRC Instrument, Ent Manual Surgical

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    Other Clearances by Sinusys Corporation

    K Number Device Name
    K133016 VENT-OS SINUS DILATION SYSTEM