FDA 510(k) Application Details - K231862

Device Classification Name	More FDA Info for this Device
510(K) Number	K231862
Device Name	TruDi« Navigation System V3 (FG-2000-00)
Applicant	Acclarent, Inc. Suite 200, 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	PGW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/23/2023
Decision Date	07/21/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	EN - Ear, Nose, & Throat
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review