510(k) K253612
K253612 is an FDA 510(k) premarket notification submitted by Acclarent, Inc. for the device "Acclarent AERA Eustachian Tube Balloon Dilation System". The FDA issued a decision of Substantially Equivalent on February 19, 2026. The device falls under product code PNZ (Eustachian Tube Balloon Dilation Device), a Class II device regulated under 21 CFR 874.4180. Acclarent, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 19, 2026
- Date Received
- November 18, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Eustachian Tube Balloon Dilation Device
- Device Class
- Class II
- Regulation Number
- 874.4180
- Review Panel
- EN
- Submission Type
The device is intended for use in dilating the cartilaginous portion of the Eustachian tube for treating persistent Eustachian tube dysfunction.