FDA.reportPublic FDA data

510(k) K220027

Device
Audion ET dilation system
Applicant
Entellus Medical, Inc.
510(k) number
K220027
Product code
PNZ
Decision
Substantially Equivalent (SESE)
Decision date
2022-04-12
Date received
2022-01-05
Regulation
874.4180
Classification name
Eustachian Tube Balloon Dilation Device
Medical specialty
Ear, Nose, Throat
Review panel
Ear, Nose, Throat
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Katie Wilson
Address
3600 Holly Ln. N., Suite 40 Plymouth MN US 55447 55447

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code PNZ#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K253612Acclarent AERA Eustachian Tube Balloon Dilation SystemAcclarent, Inc.2026-02-19
K230742ACCLARENT AERA Eustachian Tube Dilation SystemAcclarent, Inc.2023-12-13
K223542TubaVent Balloon Dilatation SystemSpiggle & Theis Medizintechnik GmbH2023-08-03
K230065VenSure™ Balloon Dilation System, VenSure™ Light Balloon Dilation System, VenSure™ Nav Balloon Dilation System, VenSure™ ET Balloon Dilation SystemFiagon GmbH2023-05-26
K210841NuVent Eustachian Tube Dilation BalloonMedtronic Xomed, Inc.2021-08-16
K171761ACCLARENT AERA Eustachian Tube Balloon Dilation SystemAcclarent, Inc.2018-01-16
K163509XprESS ENT Dilation SystemEntellus Medical, Inc.2017-04-05
DEN150056Acclarent Aera Eustachian Tube Balloon Dilation SystemAcclarent, Inc.2016-09-16