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

    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))

    K Number: K250256 · Decision Apr 28, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36
    Same Product Code
    115
    Applicant Total
    2
    Review Days
    90

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    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))
    K Number
    K250256
    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
    January 28, 2025
    Decision Date
    April 28, 2025
    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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (ETD), ordered by most recent decision date.

    Tula Tympanostomy Tube Delivery Device

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    Solo+ Tympanostomy Tube Device (TTD)

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    Biowy Tym Tube (TT)

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    Tympanostomy Tubes

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    Hummingbird Tympanostomy Tube System

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    Hummingbird Tympanostomy Tube System

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat
    View all

    Other Clearances by Aventamed Dac

    K Number Device Name
    K232702 Solo+ Tympanostomy Tube Device (TTD)