Acclarent Tympanostomy Tube and Tympanostomy Tube Delivery System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K103595 FDA 510(k)
- FDA Product Code
- ETD FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 874.3880 FDA 510(k)
- Regulation Number
- 874.3880 FDA 510(k)
- Advisory Committee
- Ear, Nose, Throat FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Acclarent Tympanostomy Tube and Tympanostomy Tube Delivery System is a medical device designed for the insertion of tympanostomy tubes through the tympanic membrane. It is classified as a tube, tympanostomy, and is intended to facilitate myringotomy procedures by delivering a preloaded Paparella-type tympanostomy tube. The system includes a button-controlled activation mechanism to ensure precise placement during the procedure.
This device is supplied as a sterile, single-use system and is intended for use in clinical settings by qualified healthcare professionals. It is regulated under FDA 510(k) clearance (K103595) and falls under the Ear, Nose, and Throat (ENT) specialty category. The system is designed for in-office procedures and is not intended for MRI use. Multiple tube sizes are available, as referenced by the associated FEI numbers, and must be stored according to manufacturer instructions to maintain sterility and functionality.
Frequently asked questions
What is the Acclarent Tympanostomy Tube Delivery System used for?
The Acclarent Tympanostomy Tube Delivery System is designed specifically for the insertion of tympanostomy tubes through the tympanic membrane during myringotomy procedures. It facilitates precise placement of preloaded Paparella-type tubes, ensuring accurate and controlled delivery to treat conditions like chronic otitis media or fluid buildup in the middle ear.
How is the Acclarent Tympanostomy Tube Delivery System supplied and what are its sterility and usage guidelines?
The system is supplied as a sterile, single-use device, ensuring safety and hygiene for each procedure. It is intended exclusively for clinical use by qualified healthcare professionals in office settings. Sterility must be maintained as per manufacturer instructions, and the system should not be reused or reprocessed.
What tube sizes are available, and how are they referenced?
Multiple tube sizes are available, each referenced by unique FEI numbers. These include identifiers such as 3003495548, 3013557562, 3003678543, and others listed in the FDA records. The correct size must be selected based on clinical assessment and patient anatomy to ensure proper function and comfort.
Can the Acclarent Tympanostomy Tube Delivery System be used in MRI procedures?
No, the system is explicitly not intended for MRI use. This limitation is due to potential compatibility issues with magnetic fields, which could compromise the integrity of the device or pose risks to the patient. Always verify device compatibility with imaging modalities before use.
How should the device be stored to maintain sterility and functionality?
The device must be stored according to the manufacturer’s instructions to preserve sterility and ensure functionality. This typically includes keeping it in its original packaging, in a clean and dry environment, protected from contamination, moisture, and extreme temperatures. Avoid exposure to direct sunlight or sources of heat.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: PDF Acclarent) 21,1I - Food and Drug Administration, Acclarent Tympanostomy Tube Delivery System (TTDS). in Otitis Media ..., Acclarent Tympanostomy Tube Delivery system (TTDS) in Otitis Media ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K103595 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Acclarent, Inc.
Sources (1)
- FDA 510(k) K103595 24 fields · synced Oct 5, 2026