Cleared Traditional

Audion ET dilation system

K220027 · Entellus Medical, Inc. · Ear, Nose, Throat

Apr 2022

Decision

97d

Days

Class 2

Risk

About This 510(k) Submission

K220027 is an FDA 510(k) clearance for the Audion ET dilation system, a Eustachian Tube Balloon Dilation Device (Class II — Special Controls, product code PNZ), submitted by Entellus Medical, Inc. (Plymouth, US). The FDA issued a Cleared decision on April 12, 2022, 97 days after receiving the submission on January 5, 2022. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4180.

Submission Details

510(k) Number	K220027 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 05, 2022
Decision Date	April 12, 2022
Days to Decision	97 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.