Cleared Traditional

ACCLARENT AERA Eustachian Tube Dilation System

K230742 · Acclarent, Inc. · Ear, Nose, Throat

Dec 2023

Decision

271d

Days

Class 2

Risk

About This 510(k) Submission

K230742 is an FDA 510(k) clearance for the ACCLARENT AERA Eustachian Tube Dilation System, a Eustachian Tube Balloon Dilation Device (Class II — Special Controls, product code PNZ), submitted by Acclarent, Inc. (Irvine, US). The FDA issued a Cleared decision on December 13, 2023, 271 days after receiving the submission on March 17, 2023. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4180.

Submission Details

510(k) Number	K230742 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 17, 2023
Decision Date	December 13, 2023
Days to Decision	271 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Summary PDF

Device Classification

Product Code	PNZ — Eustachian Tube Balloon Dilation Device
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 874.4180
Definition	The Device Is Intended For Use In Dilating The Cartilaginous Portion Of The Eustachian Tube For Treating Persistent Eustachian Tube Dysfunction.