FDA 510(k) Application Details - K230065

Device Classification Name	More FDA Info for this Device
510(K) Number	K230065
Device Name	VenSureÖ Balloon Dilation System, VenSureÖ Light Balloon Dilation System, VenSureÖ Nav Balloon Dilation System, VenSureÖ ET Balloon Dilation System
Applicant	Fiagon GmbH Neuendorfst. 23b Hennigsdorf 16761 DE Other 510(k) Applications for this Company
Contact	Dirk Mucha Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PNZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/09/2023
Decision Date	05/26/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	EN - Ear, Nose, & Throat
Review Advisory Committee	EN - Ear, Nose, & Throat
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review