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510(k) K223542

TubaVent Balloon Dilatation System by Spiggle & Theis Medizintechnik GmbH — Product Code PNZ

K223542 is an FDA 510(k) premarket notification submitted by Spiggle & Theis Medizintechnik GmbH for the device "TubaVent Balloon Dilatation System". The FDA issued a decision of Substantially Equivalent on August 3, 2023. The device falls under product code PNZ (Eustachian Tube Balloon Dilation Device), a Class II device regulated under 21 CFR 874.4180.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 3, 2023
Date Received
November 25, 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 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)
  • 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)

FDA data resources