DeviceClearance

Acclarent AERA Eustachian Tube Balloon Dilation System— 510(k) K253612

Substantially Equivalent

Acclarent, Inc.

FDA 510(k) clearance K253612 for Acclarent AERA Eustachian Tube Balloon Dilation System, Substantially Equivalent on 2026-02-19. Applicant: Acclarent, Inc..

Clearance details

Applicant
Acclarent, Inc.
Product code
Code PNZ
Advisory panel
Ear, Nose, Throat
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Irvine, CA, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.