510(k) Report

Devices descending from K961113

7 later devices reach CNS Interchangeable Bit Cranial Drill through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K252696LegacyPhasor Health, LLC20250—
+1K252514Evac-MriPhasor Health, LLC20250—
+1K122456Mrii Crainial DrillMri Interventions, Inc.20134—
+2K170442Cranial Drill Bits and AccessoriesAd-Tech Medical Instrument Corporation201702
+2K160129MRII Cranial Drill and AccessoriesMri Interventions, Inc.20161—
+2K151536SmartTwist MRII Hand Drill, SmartTip MRII Drill bit Kit, 4.5mm, 6.0mmMri Interventions, Inc.20152—
+2K132436Varioguide Drill KitMri Interventions, Inc.20140—