Cleared Traditional

K230065 - VenSure™ Balloon Dilation System, VenSure™ Light Balloon Dilation System, VenSure™ Nav Balloon Dilation System, VenSure™ ET Balloon Dilation System (FDA 510(k) Clearance)

Class II Ear, Nose, Throat device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K230065 · Fiagon GmbH · Ear, Nose, Throat device
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May 2023
Decision
137d
Days
Class 2
Risk

K230065 is an FDA 510(k) clearance for the VenSure™ Balloon Dilation System, VenSure™ Light Balloon Dilation System, Ven.... Classified as Eustachian Tube Balloon Dilation Device (product code PNZ), Class II - Special Controls.

Submitted by Fiagon GmbH (Hennigsdorf, DE). The FDA issued a Cleared decision on May 26, 2023 after a review of 137 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 Fiagon GmbH devices

Submission Details

510(k) Number K230065 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 09, 2023
Decision Date May 26, 2023
Days to Decision 137 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
48d slower than avg
Panel avg: 89d · This submission: 137d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ear, Nose, Throat devices follow this clearance model.

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 K230065.
Acclarent AERA Eustachian Tube Balloon Dilation System
K253612 · Acclarent, Inc. · Feb 2026
ACCLARENT AERA Eustachian Tube Dilation System
K230742 · Acclarent, Inc. · Dec 2023
TubaVent Balloon Dilatation System
K223542 · Spiggle & Theis Medizintechnik GmbH · Aug 2023
Audion ET dilation system
K220027 · Entellus Medical, Inc. · Apr 2022
NuVent Eustachian Tube Dilation Balloon
K210841 · Medtronic Xomed, Inc. · Aug 2021