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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 the device name listed in this FDA 510(k) record. The listed applicant is Acclarent, Inc.. It received FDA 510(k) clearance on 2026-02-19 under 510(k) 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. The listed applicant is Acclarent, Inc.. The 510(k) number is K253612.

When did Acclarent AERA Eustachian Tube Balloon Dilation System receive FDA 510(k) clearance?

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

Who is the listed applicant for Acclarent AERA Eustachian Tube Balloon Dilation System?

The FDA 510(k) record lists Acclarent, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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NCT07599826Active vs. Passive VR During Office-based ENT ProceduresNOT_YET_RECRUITINGNCT06967506Evaluation of Blowing Exercises Utilizing a Breathing Exercise Device in Otitis Media With EffusionCOMPLETED

Other records listing Acclarent, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K230742ACCLARENT AERA Eustachian Tube Dilation SystemK231862TruDi® Navigation System V3 (FG-2000-00)K221037TruDi Shaver BladeK201115Next Generation Balloon Dilation SystemK201174TruDi CuretteK193453TruDi Probe

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Related Devices (Code: PNZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K230742ACCLARENT AERA Eustachian Tube Dilation SystemAcclarent, Inc.K223542TubaVent Balloon Dilatation SystemSpiggle & Theis Medizintechnik GmbHK230065VenSure™ Balloon Dilation System, VenSure™ Light Balloon Dilation System, VenSure™ Nav Balloon Dilation System, VenSure™ ET Balloon Dilation SystemFiagon GmbHK220027Audion ET dilation systemEntellus Medical, Inc.K210841NuVent Eustachian Tube Dilation BalloonMedtronic Xomed, Inc.K171761ACCLARENT AERA Eustachian Tube Balloon 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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