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# Eustachian Tube Balloon Dilation System is Class 2
- URL: https://www.fdaweb.com/eustachian-tube-balloon-dilation-system-is-class-2/
- Published: 2016-10-24T12:00:00.000Z
- Updated: 2026-09-14T21:41:53.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5137148

*Federal Register* Final Order: FDA has classified the Eustachian tube balloon dilation system into Class 2 (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the device. To view the order, click [here](https://www.gpo.gov/fdsys/pkg/FR-2016-10-24/pdf/2016-25602.pdf?ref=fdaweb.com).