Cleared Traditional

TubaVent Balloon Dilatation System

K223542 · Spiggle & Theis Medizintechnik GmbH · Ear, Nose, Throat

Aug 2023

Decision

251d

Days

Class 2

Risk

About This 510(k) Submission

K223542 is an FDA 510(k) clearance for the TubaVent Balloon Dilatation System, a Eustachian Tube Balloon Dilation Device (Class II — Special Controls, product code PNZ), submitted by Spiggle & Theis Medizintechnik GmbH (Overath, DE). The FDA issued a Cleared decision on August 3, 2023, 251 days after receiving the submission on November 25, 2022. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4180.

Submission Details

510(k) Number	K223542 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 25, 2022
Decision Date	August 03, 2023
Days to Decision	251 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.