FDA 510(k) Application Details - K250307

Device Classification Name	Neurosurgical Laser With Mr Thermography   More FDA Info for this Device
510(K) Number	K250307
Device Name	Neurosurgical Laser With Mr Thermography
Applicant	Medtronic Navigation 200 Medtronic Drive Lafayette, CO 80026 US Other 510(k) Applications for this Company
Contact	Sharon McDermott Other 510(k) Applications for this Contact
Regulation Number	878.4810   More FDA Info for this Regulation Number
Classification Product Code	ONO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/03/2025
Decision Date	05/29/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review