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FDA 510(k)

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

K-Number: K230065 · 2023-05-26

ApplicantFiagon GmbH
Decision Date2023-05-26
Product CodePNZ
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

VenSure™ Balloon Dilation System, VenSure™ Light Balloon Dilation System, VenSure™ Nav Balloon Dilation System, VenSure™ ET Balloon Dilation System is a medical device manufactured by Fiagon GmbH. It received FDA 510(k) clearance on 2023-05-26 under approval number K230065. The device is classified under product code PNZ. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VenSure™ Balloon Dilation System, VenSure™ Light Balloon Dilation System, VenSure™ Nav Balloon Dilation System, VenSure™ ET Balloon Dilation System?

VenSure™ Balloon Dilation System, VenSure™ Light Balloon Dilation System, VenSure™ Nav Balloon Dilation System, VenSure™ ET Balloon Dilation System is a medical device that received FDA 510(k) clearance on 2023-05-26. It is manufactured by Fiagon GmbH. The 510(k) number is K230065.

When was VenSure™ Balloon Dilation System, VenSure™ Light Balloon Dilation System, VenSure™ Nav Balloon Dilation System, VenSure™ ET Balloon Dilation System approved by the FDA?

VenSure™ Balloon Dilation System, VenSure™ Light Balloon Dilation System, VenSure™ Nav Balloon Dilation System, VenSure™ ET Balloon Dilation System received FDA 510(k) clearance on 2023-05-26, under approval number K230065.

What company makes VenSure™ Balloon Dilation System, VenSure™ Light Balloon Dilation System, VenSure™ Nav Balloon Dilation System, VenSure™ ET Balloon Dilation System?

VenSure™ Balloon Dilation System, VenSure™ Light Balloon Dilation System, VenSure™ Nav Balloon Dilation System, VenSure™ ET Balloon Dilation System is manufactured by Fiagon GmbH.

What is the FDA product code for VenSure™ Balloon Dilation System, VenSure™ Light Balloon Dilation System, VenSure™ Nav Balloon Dilation System, VenSure™ ET Balloon Dilation System?

The FDA product code for VenSure™ Balloon Dilation System, VenSure™ Light Balloon Dilation System, VenSure™ Nav Balloon Dilation System, VenSure™ ET Balloon Dilation System is PNZ.

Related Clinical Trials

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Other Devices by Fiagon GmbH

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Related Devices (Code: PNZ)

DEN150056Acclarent Aera Eustachian Tube Balloon Dilation SystemAcclarent, Inc. K163509XprESS ENT Dilation SystemEntellus Medical, Inc. K171761ACCLARENT AERA Eustachian Tube Balloon Dilation SystemAcclarent, Inc. K210841NuVent Eustachian Tube Dilation BalloonMedtronic Xomed, Inc. K220027Audion ET dilation systemEntellus Medical, Inc. K230742ACCLARENT AERA Eustachian Tube Dilation SystemAcclarent, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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