510(k) Report

Devices descending from K211367

2 later devices reach Evo sEEG System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K222404Evo® sEEG SystemNeuroone Medical Technologies Corp.20221—
+2K250363Depth Electrode (RSDE-08); Depth Electrode (RSDE-10); Depth Electrode (RSDE-12); Depth…Beijing Sinovation Medical Technology Co., Ltd.20250—