DeviceClearance

ACCLARENT AERA Eustachian Tube Dilation System— 510(k) K230742

Substantially Equivalent

Acclarent, Inc.

FDA 510(k) clearance K230742 for ACCLARENT AERA Eustachian Tube Dilation System, Substantially Equivalent on 2023-12-13. 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
Download summary PDFView on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.