510(k) Report

Devices descending from K041604

12 later devices reach Macro-Micro Depth Electrode through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K163355Depth Electrodes, Foramen Ovale Depth Eletrodes, Marco-Micro Depth Electrodes, Spencer…Ad-Tech Medical Instrument Corporation201755
+1K053358Depth Electrode, Foramen Ovale Depth Electrodes, Wyler Sphenoidal Depth ElectrodesAd-Tech Medical Instrument Corp200611—
+2K250363Depth Electrode (RSDE-08); Depth Electrode (RSDE-10); Depth Electrode (RSDE-12); Depth…Beijing Sinovation Medical Technology Co., Ltd.20250—
+2K223269Spencer Probe Depth ElectrodesAd-Tech Medical Instrument Corporation20230—
+2K202087DIXI Medical Microdeep Micro-Macro Depth ElectrodesDixi Medical20210—
+2K201678iCE-SG Subcutaneous Electrode ArraysIce Neurosystems, Inc.20211—
+2K170959DIXI Medical Microdeep Depth ElectrodeDixi Medical201759
+3K213170SENSOSEEG Depth ElectrodesSensomedical Labs, Ltd.20231—
+3K222706iCE-SG2 Subcutaneous Electrode KitIce Neurosystems, Inc.20220—
+3K211367Evo sEEG SystemNeuroone Medical Technologies Corp.20212—
+4K253970Wovyn Depth ElectrodeSensomedical Labs, Ltd.20260—
+4K222404Evo® sEEG SystemNeuroone Medical Technologies Corp.20221—