Cleared Traditional

K163509 - XprESS ENT Dilation System

K163509 is an FDA 510(k) clearance for XprESS ENT Dilation System, manufactured by Entellus Medical, Inc.. The device is a Class 2 Ear, Nose, Throat device with product code PNZ cleared through the Traditional 510(k) pathway after a 111-day FDA review.

K163509 · Entellus Medical, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2017
Decision
111d
Days
Class 2
Risk

K163509 is an FDA 510(k) clearance for the XprESS ENT Dilation System. Classified as Eustachian Tube Balloon Dilation Device (product code PNZ), Class II - Special Controls.

Submitted by Entellus Medical, Inc. (Plymouth, US). The FDA issued a Cleared decision on April 5, 2017 after a review of 111 days - within the typical 510(k) review window.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.4180 - the FDA ear, nose and throat device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ear, Nose, Throat review framework, consistent with the majority of Class II 510(k) submissions.

View all Entellus Medical, Inc. devices

FDA 510(k) Submission Details - K163509

510(k) Number K163509 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
21d slower than avg
Panel avg: 90d · This submission: 111d
Pathway characteristics
Predicate-based equivalence.

PNZ Device Classification - Class 2, Special Controls

Product Code PNZ Eustachian Tube Balloon Dilation Device
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Ear, Nose, Throat devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT02391584 Completed Interventional Industry-sponsored

XprESS Eustachian Tube Dilation Study

60
Patients (actual)
5
Sites
Treatment
Purpose
Open label
Masking
Condition studied Eustachian Tube Dysfunction
Study design Crossover
Eligibility All sexes · 18 Years+
Sponsor Entellus Medical, Inc. (industry)
Started 2015-02-01 → Primary completion 2017-03-01 → Completed 2017-10-01
Primary outcome
Change From Baseline in Mean Overall ETDQ-7 Scores
Secondary outcome
Technical Success Rate
View full study on ClinicalTrials.gov

Regulatory Peers - PNZ Eustachian Tube Balloon Dilation Device

All 8
Devices cleared under the same product code (PNZ) and FDA review panel - the closest regulatory comparables to K163509.
Audion ET dilation system
K220027 · Entellus Medical, Inc. · Apr 2022
NuVent Eustachian Tube Dilation Balloon
K210841 · Medtronic Xomed, Inc. · Aug 2021
ACCLARENT AERA Eustachian Tube Balloon Dilation System
K171761 · Acclarent, Inc. · Jan 2018
Acclarent Aera Eustachian Tube Balloon Dilation System
DEN150056 · Acclarent, Inc. · Sep 2016