510(k) Report

Devices descending from K151536

2 later devices reach SmartTwist MRII Hand Drill, SmartTip MRII Drill bit Kit, 4.5mm, 6.0mm through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K160129MRII Cranial Drill and AccessoriesMri Interventions, Inc.20161—
+2K170442Cranial Drill Bits and AccessoriesAd-Tech Medical Instrument Corporation201702