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510(k) K220027

Audion ET dilation system by Entellus Medical, Inc. — Product Code PNZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 12, 2022
Date Received
January 5, 2022
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 Entellus Medical, Inc.

  • K163435 — Entellus Medical Reinforced Anesthesia Needle (April 5, 2017)
  • K163509 — XprESS ENT Dilation System (April 5, 2017)
  • K152434 — XprESS Multi-Sinus Dilation System (November 20, 2015)
  • K152435 — PassAssist LED Light Fiber (November 20, 2015)
  • K142252 — XprESS Multi-Sinus Dilation Tool (October 17, 2014)
  • K141916 — PATHASSIST LED LIGHT FIBER (August 7, 2014)
  • K133563 — PATHASSIST LIGHT SEEKER (December 20, 2013)
  • K132440 — XPRESS MULTI-SINUS DILATION TOOL (October 4, 2013)
  • K130503 — PATHASSIST LED LIGHT FIBER (June 11, 2013)
  • K121943 — XPRESS MULTI-SINUS DILATION TOOL (August 22, 2012)

Other clearances for product code PNZ

  • K253612 — Acclarent AERA Eustachian Tube Balloon Dilation System (February 19, 2026)
  • K230742 — ACCLARENT AERA Eustachian Tube Dilation System (December 13, 2023)
  • K223542 — TubaVent Balloon Dilatation System (August 3, 2023)
  • K230065 — VenSure™ Balloon Dilation System, VenSure™ Light Balloon Dilation System, VenSur (May 26, 2023)
  • 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)