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

    ClearUP Sinus Relief

    K Number: DEN200006 · Decision Mar 5, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    0
    Applicant Total
    2
    Review Days
    392

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    Basic Information

    Device Name
    ClearUP Sinus Relief
    K Number
    DEN200006
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    874.6000
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Unknown
    Applicant
    Tivic Health Systems, Inc.
    Date Received
    February 7, 2020
    Decision Date
    March 5, 2021
    Product Code
    QNU
    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
    QNU Transcutaneous Electrical Nerve Stimulator For The Relief Of Congestion

    Other Clearances by Tivic Health Systems, Inc.

    K Number Device Name
    K182025 ClearUP Sinus Pain Relief