ClearPoint Neuro, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
12
Inspections
2
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K243657ClearPoint System (Software Version 3.0)January 24, 2025
DEN240023SmartFlow Neuro CannulaNovember 13, 2024
K233703Bone Anchor (NGS-BA-01)April 26, 2024
K233144ClearPoint Bone Screw FiducialsJanuary 12, 2024
K233155ClearPointer Optical Navigation WandJanuary 12, 2024
K233141SmartFrame ORJanuary 12, 2024
K233243ClearPoint System (Software Version 2.2)November 27, 2023
K232102ClearPoint Array System (Version 1.2)September 15, 2023
K222519ClearPoint SystemSeptember 16, 2022
K213645ClearPoint Maestro Brain ModelAugust 8, 2022
K214040ClearPoint Array System (version 1.1)April 12, 2022
K202575ClearPoint Array SystemJanuary 22, 2021