FDA 510(k) Application Details - DEN240023

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN240023
Device Name	SmartFlow Neuro Cannula
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	More FDA Info for this Regulation Number
Classification Product Code	SDG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/22/2024
Decision Date	11/13/2024
Decision	DENG -
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review