Cleared Traditional

ACCLARENT AERA Eustachian Tube Balloon Dilation System

K171761 · Acclarent, Inc. · Ear, Nose, Throat

Jan 2018

Decision

216d

Days

Class 2

Risk

About This 510(k) Submission

K171761 is an FDA 510(k) clearance for the ACCLARENT AERA Eustachian Tube Balloon Dilation System, a Eustachian Tube Balloon Dilation Device (Class II — Special Controls, product code PNZ), submitted by Acclarent, Inc. (Irvin, US). The FDA issued a Cleared decision on January 16, 2018, 216 days after receiving the submission on June 14, 2017. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4180.

Submission Details

510(k) Number	K171761 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 14, 2017
Decision Date	January 16, 2018
Days to Decision	216 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.