510(k) Report

Devices descending from K141368

2 later devices reach Neuropace Burr Hole Cover through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K152342Guardian Burr Hole Cover System, Guardian Screw, Burr Hole CoverSt Jude Medical20161—
+2K181382GuardianTM Burr Hole Cover SystemSt Jude Medical20180—