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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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    K Number
    K200952
    Device Name
    Hummingbird Tympanostomy Tube System
    Manufacturer
    Preceptis Medical, Inc
    Date Cleared
    2020-06-05

    (57 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 of the patient and is indicated to be used in office settings for children 6-24 months old.
    Device Description
    The Hummingbird® Tympanostomy Tube System (HTTS), which includes a preloaded ventilation tube, is a single-use, sterile manual surgical instrument. The HTTS 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 surgeon 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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    K Number
    K151830
    Device Name
    Hummingbird Tympanostomy Tube
    Manufacturer
    PRECEPTIS MEDICAL
    Date Cleared
    2015-09-21

    (77 days)

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

    PRECEPTIS MEDICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Indicated where chronic Eustachian tube dysfunction does not respond to conventional therapy.
    Device Description
    The tympanostomy tube is a silicone tube that is intended to provide ventilation and drainage to the middle ear.
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    K Number
    K142282
    Device Name
    HUMMINGBIRD(TM) TYMPANOSTOMY TUBE SYSTEM (TTS)
    Manufacturer
    PRECEPTIS MEDICAL
    Date Cleared
    2015-04-23

    (251 days)

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

    PRECEPTIS MEDICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Hummingbird™ Tympanostomy Tube System is intended to deliver a tympanostomy tube in tympanostomy procedures in which the patient is receiving a tympanostomy tube.
    Device Description
    The Hummingbird™ Tympanostomy Tube System (TTS) which includes a tympanostomy tube inserter (TTI) with 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 TTS includes a handle with one or more tip assemblies which contain a sterile tympanostomy tube. Each tip assembly can be removably attached to the handle and includes a positioning rod and a ventilation tube pre-loaded inside the distal end of a sharpened sheath. Attaching the tip assembly to the handle also connects the sheath and actuator, allowing the user to retract the sheath by manually scrolling an actuator located on the handle. The user 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. A first tip assembly can then be removed from the handle and replaced with a second preloaded tip assembly for bilateral
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    K Number
    K133921
    Device Name
    PRECEPTIS TYMPANOSTOMY TUBE INSERTER
    Manufacturer
    PRECEPTIS MEDICAL
    Date Cleared
    2014-08-22

    (242 days)

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

    PRECEPTIS MEDICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Tympanostomy Tube System is intended to deliver a tympanostomy tube in tympanostomy procedures in which the patient is receiving a tympanostomy tube.
    Device Description
    The Preceptis Tympanostomy Tube System (TTS) which includes a tympanostomy tube inserter (TTI) with 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 TTI comprises a handle with one or more tip assemblies which contain a sterile tympanostomy tube. Each tip assembly can be removably attached to the handle and includes a positioning rod and a ventilation tube pre-loaded inside the distal end of a sharpened sheath. Attaching the tip assembly to the handle also connects the sheath and actuator, allowing the user to retract the sheath by manually scrolling an actuator located on the handle. The user 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. A first tip assembly can then be removed from the handle and replaced with a second preloaded tip assembly for bilateral procedures.
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