FDA 510(k) Applications for Medical Device Product Code: PNZ ()

FDA 510(k) Applications for Medical Device Product Code "PNZ"

FDA 510(k) Number	Applicant	Device Name	Decision Date
DEN150056	ACCLARENT, INC.	Acclarent Aera Eustachian Tube Balloon Dilation System	09/16/2016
K171761	Acclarent, Inc.	ACCLARENT AERA Eustachian Tube Balloon Dilation System	01/16/2018
K220027	Entellus Medical, Inc.	Audion ET dilation system	04/12/2022
K163509	Entellus Medical, Inc.	XprESS ENT Dilation System	04/05/2017
K230065	Fiagon GmbH	VenSureÖ Balloon Dilation System, VenSureÖ Light Balloon Dilation System, VenSureÖ Nav Balloon Dilation System, VenSureÖ ET Balloon Dilation System	05/26/2023
K210841	Medtronic Xomed, Inc.	NuVent Eustachian Tube Dilation Balloon	08/16/2021
K223542	Spiggle & Theis Medizintechnik GmbH	TubaVent Balloon Dilatation System	08/03/2023