BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇪 Ireland

    Solo+ Tympanostomy Tube Device (TTD)

    K Number: K232702 · Decision May 20, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36
    Same Product Code
    115
    Applicant Total
    2
    Review Days
    258

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    Basic Information

    Device Name
    Solo+ Tympanostomy Tube Device (TTD)
    K Number
    K232702
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.3880
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Aventamed Dac
    Date Received
    September 5, 2023
    Decision Date
    May 20, 2024
    Product Code
    ETD
    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
    ETD Tube, Tympanostomy

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    Other Clearances by Aventamed Dac

    K Number Device Name
    K250256 Solo+ Tympanostomy Tube Device (TTD), Solo+ TTD, Solo+ (Solo+ Tympanostomy Tube Handpiece (Catalogue #: 12115-100-000) and Solo+ Tympanostomy Tube Cartridge (Catalogue #: 12115-200-000))