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510(k) Data Aggregation
K Number
K221254Device Name
Hummingbird Tympanostomy Tube System
Manufacturer
Preceptis Medical, Inc.
Date Cleared
2022-07-27
(86 days)
Product Code
ETD
Regulation Number
874.3880Why 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
K200952Device Name
Hummingbird Tympanostomy Tube System
Manufacturer
Preceptis Medical, Inc
Date Cleared
2020-06-05
(57 days)
Product Code
ETD
Regulation Number
874.3880Why 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
K151830Device Name
Hummingbird Tympanostomy Tube
Manufacturer
PRECEPTIS MEDICAL
Date Cleared
2015-09-21
(77 days)
Product Code
ETD
Regulation Number
874.3880Why 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
K142282Device Name
HUMMINGBIRD(TM) TYMPANOSTOMY TUBE SYSTEM (TTS)
Manufacturer
PRECEPTIS MEDICAL
Date Cleared
2015-04-23
(251 days)
Product Code
ETD
Regulation Number
874.3880Why 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
K133921Device Name
PRECEPTIS TYMPANOSTOMY TUBE INSERTER
Manufacturer
PRECEPTIS MEDICAL
Date Cleared
2014-08-22
(242 days)
Product Code
ETD
Regulation Number
874.3880Why 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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