FDA 510(k) Applications Submitted by ClearPoint Neuro, Inc.

FDA 510(k) Number Submission Date Device Name Applicant
DEN240023 05/22/2024 SmartFlow Neuro Cannula ClearPoint Neuro, Inc.
K232102 07/14/2023 ClearPoint Array System (Version 1.2) ClearPoint Neuro, Inc.
K243657 11/27/2024 ClearPoint System (Software Version 3.0) ClearPoint Neuro, Inc.
K222519 08/19/2022 ClearPoint System ClearPoint Neuro, Inc.
K202575 09/04/2020 ClearPoint Array System ClearPoint Neuro, Inc.
K213645 11/18/2021 ClearPoint Maestro Brain Model ClearPoint Neuro, Inc.
K214040 12/23/2021 ClearPoint Array System (version 1.1) ClearPoint Neuro, Inc.


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