FDA 510(k) Application Details - K230742

Device Classification Name	More FDA Info for this Device
510(K) Number	K230742
Device Name	ACCLARENT AERA Eustachian Tube Dilation System
Applicant	Acclarent, Inc. 31 Technology Drive Irvine, CA 92618 US Other 510(k) Applications for this Company
Contact	Kamrie Sarnosky 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	03/17/2023
Decision Date	12/13/2023
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