Medical Device Manufacturer · US , Irvine , CA

ClearPoint Neuro, Inc. - FDA 510(k) Cleared Devices

12 submissions · 11 cleared · Since 2021

12

Total

11

Cleared

1

Denied

FDA 510(k) Regulatory Record - ClearPoint Neuro, Inc. Radiology ✕

1 devices

1-1 of 1

Cleared Aug 08, 2022

ClearPoint Maestro Brain Model

Radiology · 263d

Data Source

Sourced from the FDA 510(k) public files . 174,883 total devices indexed.

Last updated: May 05, 2026