510(k) Report

Devices descending from K123163

5 later devices reach Neuropace Burr Hole Cover Model 8110 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K160739Cranial COVERNeos Surgery S.L20161—
+1K152342Guardian Burr Hole Cover System, Guardian Screw, Burr Hole CoverSt Jude Medical20161—
+1K141368Neuropace Burr Hole CoverNeuroPace, Inc.20142—
+2K192310Flap Fixator, Burr Hole CoverOssaware Biotech Co., Ltd.20200—
+2K181382GuardianTM Burr Hole Cover SystemSt Jude Medical20180—