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FDA 510(k)

Acclarent AERA Eustachian Tube Balloon Dilation System

K-Number: K253612 · 2026-02-19

ApplicantAcclarent, Inc.
Decision Date2026-02-19
Product CodePNZ
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

Acclarent AERA Eustachian Tube Balloon Dilation System is a medical device manufactured by Acclarent, Inc.. It received FDA 510(k) clearance on 2026-02-19 under approval number K253612. 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 Acclarent AERA Eustachian Tube Balloon Dilation System?

Acclarent AERA Eustachian Tube Balloon Dilation System is a medical device that received FDA 510(k) clearance on 2026-02-19. It is manufactured by Acclarent, Inc.. The 510(k) number is K253612.

When was Acclarent AERA Eustachian Tube Balloon Dilation System approved by the FDA?

Acclarent AERA Eustachian Tube Balloon Dilation System received FDA 510(k) clearance on 2026-02-19, under approval number K253612.

What company makes Acclarent AERA Eustachian Tube Balloon Dilation System?

Acclarent AERA Eustachian Tube Balloon Dilation System is manufactured by Acclarent, Inc..

What is the FDA product code for Acclarent AERA Eustachian Tube Balloon Dilation System?

The FDA product code for Acclarent AERA Eustachian Tube Balloon Dilation System is PNZ.

Related Clinical Trials

NCT07195708 Orbera365 Intragastric Balloon System (Abbreviated as'Orbera365') NOT_YET_RECRUITING NCT05147363 Shockwave: Disruption for A Better Fit WITHDRAWN NCT07181590 BaLloon-based PFA Ablation poST Approval Outcomes for PAF and PersAF RECRUITING NCT07211035 Effect of the Amplifi™ Vein Dilation System on Outflow Vein Dilation and AV Fistula Maturation (AMPLIFI-1) RECRUITING NCT07599826 Active vs. Passive VR During Office-based ENT Procedures NOT_YET_RECRUITING NCT07062094 Safety and Effectiveness of Orbera365™ Intragastric Balloon System RECRUITING

Other Devices by Acclarent, Inc.

K161697Acclarent NavWire Sinus Navigation Guidewire K161698Relieva UltirraNav Sinus Balloon Catheter DEN150056Acclarent Aera Eustachian Tube Balloon Dilation System K153341Relieva Scout Multi-Sinus Dilation System K171687Relieva SpinPlus Nav Balloon Sinuplasty System K180948TruDi NAV Suction Instruments

View all 18 devices →

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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