510(k) Report

Devices descending from K991077

21 later devices reach Microelectroencephalography Professional System 5000 (Eeg Pro System 5000) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K033173Micro Targeting ElectrodeFHC, Inc.200416—
+1K012850Recording and Stimulating ElectrodeRadionics, A Division of Tyco Healthcare Group LP20016—
+1K011775Micro Targeting Drive SystemFHC, Inc.20011Class I
+1K991522Microtargeting ElectrodeFHC, Inc.2000173
+2K170959DIXI Medical Microdeep Depth ElectrodeDixi Medical201759
+2K162459AccuPoint ElectrodeMicroprobes For Life Science, Inc. Dba Neuron20170—
+2K082404Navigation ProbesWe Sense, Ltd.20090—
+2K041409Micro-Recording and Stimulation Electrodes-Micro Macroelectrode Model NO. 230700-230799Inomed GmbH20040—
+2K041604Macro-Micro Depth ElectrodeAd-Tech Medical Instrument Corp200412—
+2K040979Elekta Microdrive, Model 916716Elekta Instrument AB20040—
+3K250363Depth Electrode (RSDE-08); Depth Electrode (RSDE-10); Depth Electrode (RSDE-12); Depth…Beijing Sinovation Medical Technology Co., Ltd.20250—
+3K213170SENSOSEEG Depth ElectrodesSensomedical Labs, Ltd.20231—
+3K211367Evo sEEG SystemNeuroone Medical Technologies Corp.20212—
+3K163355Depth Electrodes, Foramen Ovale Depth Eletrodes, Marco-Micro Depth Electrodes, Spencer…Ad-Tech Medical Instrument Corporation201755
+3K053358Depth Electrode, Foramen Ovale Depth Electrodes, Wyler Sphenoidal Depth ElectrodesAd-Tech Medical Instrument Corp200611—
+4K253970Wovyn Depth ElectrodeSensomedical Labs, Ltd.20260—
+4K223269Spencer Probe Depth ElectrodesAd-Tech Medical Instrument Corporation20230—
+4K222404Evo® sEEG SystemNeuroone Medical Technologies Corp.20221—
+4K202087DIXI Medical Microdeep Micro-Macro Depth ElectrodesDixi Medical20210—
+4K201678iCE-SG Subcutaneous Electrode ArraysIce Neurosystems, Inc.20211—
+5K222706iCE-SG2 Subcutaneous Electrode KitIce Neurosystems, Inc.20220—