ClearPoint Neuro, Inc. - FDA 510(k) Cleared Devices
Recent clearances: ClearPoint System (Software Version 3.0), Bone Anchor (NGS-BA-01), SmartFrame OR
12
Total
11
Cleared
1
Denied
FDA 510(k) Regulatory Record - ClearPoint Neuro, Inc. Neurology ✕
11 devices
Cleared
Jan 24, 2025
ClearPoint System (Software Version 3.0)
Neurology
58d
Not Cleared
Nov 13, 2024
SmartFlow Neuro Cannula
Neurology
175d
Cleared
Apr 26, 2024
Bone Anchor (NGS-BA-01)
Neurology
161d
Cleared
Jan 12, 2024
SmartFrame OR
Neurology
107d
Cleared
Jan 12, 2024
ClearPoint Bone Screw Fiducials
Neurology
107d
Cleared
Jan 12, 2024
ClearPointer Optical Navigation Wand
Neurology
107d
Cleared
Nov 27, 2023
ClearPoint System (Software Version 2.2)
Neurology
60d
Cleared
Sep 15, 2023
ClearPoint Array System (Version 1.2)
Neurology
63d
Cleared
Sep 16, 2022
ClearPoint System
Neurology
28d
Cleared
Apr 12, 2022
ClearPoint Array System (version 1.1)
Neurology
110d
Cleared
Jan 22, 2021
ClearPoint Array System
Neurology
140d