510(k) Report

Devices descending from K200079

3 later devices reach ClearPoint System and Accessories through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K202575ClearPoint Array SystemClearPoint Neuro, Inc.20212—
+2K232102ClearPoint Array System (Version 1.2)ClearPoint Neuro, Inc.20230—
+2K214040ClearPoint Array System (version 1.1)ClearPoint Neuro, Inc.20221—