510(k) Report

Devices descending from K012850

6 later devices reach Recording and Stimulating Electrode through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K170959DIXI Medical Microdeep Depth ElectrodeDixi Medical201759
+2K250363Depth Electrode (RSDE-08); Depth Electrode (RSDE-10); Depth Electrode (RSDE-12); Depth…Beijing Sinovation Medical Technology Co., Ltd.20250—
+2K213170SENSOSEEG Depth ElectrodesSensomedical Labs, Ltd.20231—
+2K211367Evo sEEG SystemNeuroone Medical Technologies Corp.20212—
+3K253970Wovyn Depth ElectrodeSensomedical Labs, Ltd.20260—
+3K222404Evo® sEEG SystemNeuroone Medical Technologies Corp.20221—