Cleared Traditional

VenSure? Balloon Dilation System, VenSure? Light Balloon Dilation System, VenSure? Nav Balloon Dilation System, VenSure? ET Balloon Dilation System

K230065 · Fiagon GmbH · Ear, Nose, Throat

May 2023

Decision

137d

Days

Class 2

Risk

About This 510(k) Submission

K230065 is an FDA 510(k) clearance for the VenSure? Balloon Dilation System, VenSure? Light Balloon Dilation System, VenSure? Nav Balloon Dilation System, VenSure? ET Balloon Dilation System, a Eustachian Tube Balloon Dilation Device (Class II — Special Controls, product code PNZ), submitted by Fiagon GmbH (Hennigsdorf, DE). The FDA issued a Cleared decision on May 26, 2023, 137 days after receiving the submission on January 9, 2023. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4180.

Submission Details

510(k) Number	K230065 FDA.gov
FDA Decision	Cleared 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

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.