FDA 510(k) Applications Submitted by Brennan Sullivan

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.
K233141 09/27/2023 SmartFrame OR ClearPoint Neuro Inc.
K233144 09/27/2023 ClearPoint Bone Screw Fiducials ClearPoint Neuro Inc.
K233155 09/27/2023 ClearPointer Optical Navigation Wand ClearPoint Neuro Inc.
K233243 09/28/2023 ClearPoint System (Software Version 2.2) ClearPoint Neuro Inc.
K233703 11/17/2023 Bone Anchor (NGS-BA-01) ClearPoint Neuro Inc.
K243657 11/27/2024 ClearPoint System (Software Version 3.0) ClearPoint Neuro, Inc.


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