FDA 510(k) Application Details - K250752

Device Classification Name	Endoscope, Neurological   More FDA Info for this Device
510(K) Number	K250752
Device Name	Endoscope, Neurological
Applicant	Integra LifeSciences Corporation 1100 Campus Rd. Princeton, NJ 08540 US Other 510(k) Applications for this Company
Contact	Rebecca Odulio Other 510(k) Applications for this Contact
Regulation Number	882.1480   More FDA Info for this Regulation Number
Classification Product Code	GWG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/12/2025
Decision Date	04/09/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review