Audion ET Dilation System

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K220027 ↗

FDA Product Code

PNZ

FDA applicant

Entellus Medical, Inc.

Device Class

Class II

Regulation

21 CFR Part 874.4180

Advisory Committee

Ear, Nose, Throat

FDA Decision

SESE Substantially Equivalent

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• What is the Audion ET dilation system designed to treat, and who should use it?

  The Audion ET dilation system is specifically designed to mechanically widen the Eustachian tube, helping to relieve Eustachian tube dysfunction. This condition can cause issues like pressure imbalances or ventilation problems in the middle ear, often leading to symptoms like ear fullness or popping. It is intended for use by qualified healthcare professionals in clinical settings, such as ENT (ear, nose, and throat) specialists, to perform the dilation procedure.

• Is the Audion ET dilation system reusable or single-use, and how should it be stored?

  The Audion ET dilation system is supplied as a single-use, sterile medical device, meaning it is intended for one-time use only and should not be reused. Since it is sterile, it should be stored in its original packaging until ready for use, following the manufacturer’s instructions to maintain sterility and integrity. Proper storage conditions, such as avoiding extreme temperatures or moisture, are critical to preserving its functionality.

• What regulatory pathway was used for FDA clearance of the Audion ET dilation system, and what does that mean for its use?

  The Audion ET dilation system received FDA clearance through the Traditional 510(k) pathway, which means it was determined to be substantially equivalent to a legally marketed predicate device. This clearance confirms that the device meets FDA standards for safety and effectiveness as intended for its use in mechanically dilating the Eustachian tube. The product code PNZ and classification under 21 CFR 874.4180 further indicate its regulatory classification as a Class II device.

• Are there different sizes or models of the Audion ET dilation system, and if so, how do they differ?

  The data provided lists multiple registration numbers associated with the Audion ET dilation system, which may correspond to different lot or batch identifiers rather than distinct sizes or models. However, the system itself is described as a single device type for Eustachian tube dilation. If specific sizes or variations exist, they would likely be detailed in the manufacturer’s instructions or product documentation, but no explicit differences are mentioned in the available regulatory data.