FDA 510(k) Application Details - K233243

Device Classification Name	Neurological Stereotaxic Instrument   More FDA Info for this Device
510(K) Number	K233243
Device Name	Neurological Stereotaxic Instrument
Applicant	ClearPoint Neuro Inc. 120 S. Sierra Ave. Suite 100 Solana Beach, CA 92075 US Other 510(k) Applications for this Company
Contact	Brennan Sullivan Other 510(k) Applications for this Contact
Regulation Number	882.4560   More FDA Info for this Regulation Number
Classification Product Code	HAW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/28/2023
Decision Date	11/27/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review