510(k) Report

Devices descending from K170959

5 later devices reach DIXI Medical Microdeep Depth Electrode through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K250363Depth Electrode (RSDE-08); Depth Electrode (RSDE-10); Depth Electrode (RSDE-12); Depth…Beijing Sinovation Medical Technology Co., Ltd.20250—
+1K213170SENSOSEEG Depth ElectrodesSensomedical Labs, Ltd.20231—
+1K211367Evo sEEG SystemNeuroone Medical Technologies Corp.20212—
+2K253970Wovyn Depth ElectrodeSensomedical Labs, Ltd.20260—
+2K222404Evo® sEEG SystemNeuroone Medical Technologies Corp.20221—