Cleared Traditional

XprESS ENT Dilation System

K163509 · Entellus Medical, Inc. · Ear, Nose, Throat

Apr 2017

Decision

111d

Days

Class 2

Risk

About This 510(k) Submission

K163509 is an FDA 510(k) clearance for the XprESS ENT 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 5, 2017, 111 days after receiving the submission on December 15, 2016. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4180.

Submission Details

510(k) Number	K163509 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 15, 2016
Decision Date	April 05, 2017
Days to Decision	111 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.