Home / 510(k) Clearances / K230065

510(k) K230065

VenSure™ Balloon Dilation System, VenSure™ Light Balloon Dilation System, VenSure™ Nav Balloon Dilation System, VenSure™ ET Balloon Dilation System by Fiagon GmbH — Product Code PNZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 26, 2023
Date Received
January 9, 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 Fiagon GmbH

  • K230700 — RIWOtrack Navigation System (November 20, 2023)
  • K211291 — Cube Navigation System, VirtuEye V2, Navigation Sensor NanoRest, Navigation Unit (July 19, 2021)
  • K201472 — VenSure Balloon Device, VenSure Nav Balloon Device (August 26, 2020)
  • K200041 — FlexPointer 1.5 Single Use, FlexTube 3 Single Use (March 10, 2020)
  • K163209 — Fiagon Navigation System (September 14, 2017)
  • K163416 — Fiagon Navigation – PointerTube Straight and PointerTube Keat (February 16, 2017)
  • K162176 — Fiagon Navigation System (December 1, 2016)
  • K161940 — Guidewire 0.6 Single Use (September 18, 2016)
  • K151156 — Fiagon Navigation System (April 1, 2016)
  • K160479 — PointerShell Universal, PointerShell LS (March 23, 2016)

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)
  • 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)