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510(k) Data Aggregation

    K Number
    K221254
    Device Name
    Hummingbird Tympanostomy Tube System
    Manufacturer
    Preceptis Medical, Inc.
    Date Cleared
    2022-07-27

    (86 days)

    Product Code
    ETD
    Regulation Number
    874.3880
    Why did this record match?
    Applicant Name (Manufacturer) :

    Preceptis Medical, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Hummingbird® Tympanostomy Tube System (HTTS) is intended to deliver a tympanostomy tube (also referred to as a ventilation tube) through the tympanic membrane of the patient and is indicated to be used in office settings for pediatric patients 6 months and older.
    Device Description
    The Hummingbird® Tympanostomy Tube System (HTTS), which includes a preloaded ventilation tube, is a single-use, sterile manual surgical instrument which is used to create a myringotomy in the tympanic membrane and place a ventilation tube. The surgeon manually advances the sharpened sheath to create a myringotomy and simultaneously positions the ventilation tube within the myringotomy, always under direct visualization. The user then manually retracts the sharpened sheath away from the myringotomy using the manual actuator located on the handle. The retraction of the sheath releases the tube within the myringotomy.
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