FDA 510(k) Application Details - K243053

Device Classification Name	More FDA Info for this Device
510(K) Number	K243053
Device Name	Navient Image Guided Navigation System (ENT) (955-NC-NC)
Applicant	ClaroNav 1140 Sheppard Avenue West Unit 10 Toronto M3K2A2 CA Other 510(k) Applications for this Company
Contact	Karen Wu 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	09/27/2024
Decision Date	06/20/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	EN - Ear, Nose, & Throat
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review