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510(k) K230742

ACCLARENT AERA Eustachian Tube Dilation System by Acclarent, Inc. — Product Code PNZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 13, 2023
Date Received
March 17, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Eustachian Tube Balloon Dilation Device
Device Class
Class II
Regulation Number
874.4180
Review Panel
EN
Submission Type

The device is intended for use in dilating the cartilaginous portion of the Eustachian tube for treating persistent Eustachian tube dysfunction.

Other clearances by Acclarent, Inc.

  • K253612 — Acclarent AERA Eustachian Tube Balloon Dilation System (February 19, 2026)
  • K231862 — TruDi® Navigation System V3 (FG-2000-00) (July 21, 2023)
  • K221037 — TruDi Shaver Blade (July 20, 2022)
  • K201115 — Next Generation Balloon Dilation System (August 27, 2020)
  • K201174 — TruDi Curette (August 12, 2020)
  • K193453 — TruDi Probe (March 23, 2020)
  • K190525 — RELIEVA ULTIRRA Sinus Balloon Catheter (May 3, 2019)
  • K190532 — TruDi NAV Wire (May 3, 2019)
  • K183090 — Relieva Tract Balloon Dilation System (April 19, 2019)
  • K180948 — TruDi NAV Suction Instruments (July 20, 2018)

Other clearances for product code PNZ

  • K253612 — Acclarent AERA Eustachian Tube Balloon Dilation System (February 19, 2026)
  • K223542 — TubaVent Balloon Dilatation System (August 3, 2023)
  • K230065 — VenSure™ Balloon Dilation System, VenSure™ Light Balloon Dilation System, VenSur (May 26, 2023)
  • K220027 — Audion ET dilation system (April 12, 2022)
  • K210841 — NuVent Eustachian Tube Dilation Balloon (August 16, 2021)
  • K171761 — ACCLARENT AERA Eustachian Tube Balloon Dilation System (January 16, 2018)
  • K163509 — XprESS ENT Dilation System (April 5, 2017)
  • DEN150056 — Acclarent Aera Eustachian Tube Balloon Dilation System (September 16, 2016)