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

    Hummingbird Tympanostomy Tube System

    K Number: K200952 · Decision Jun 5, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36
    Same Product Code
    115
    Applicant Total
    2
    Review Days
    57

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    Basic Information

    Device Name
    Hummingbird Tympanostomy Tube System
    K Number
    K200952
    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
    Preceptis Medical, Inc.
    Date Received
    April 9, 2020
    Decision Date
    June 5, 2020
    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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    Hummingbird Tympanostomy Tube System

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    Other Clearances by Preceptis Medical, Inc.

    K Number Device Name
    K221254 Hummingbird Tympanostomy Tube System