510(k) Report

Devices descending from K944463

20 later devices reach CRW-1 System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K160811CRW Stereotactic SystemIntegra LifeSciences Corporation20160—
+1K961858Cosgrove Depth Electrode Kit (Cdek)Radionics, Inc.199618—
+2K033173Micro Targeting ElectrodeFHC, Inc.200416—
+2K991522Microtargeting ElectrodeFHC, Inc.2000173
+3K162459AccuPoint ElectrodeMicroprobes For Life Science, Inc. Dba Neuron20170—
+3K082404Navigation ProbesWe Sense, Ltd.20090—
+3K041409Micro-Recording and Stimulation Electrodes-Micro Macroelectrode Model NO. 230700-230799Inomed GmbH20040—
+3K041604Macro-Micro Depth ElectrodeAd-Tech Medical Instrument Corp200412—
+4K163355Depth Electrodes, Foramen Ovale Depth Eletrodes, Marco-Micro Depth Electrodes, Spencer…Ad-Tech Medical Instrument Corporation201755
+4K053358Depth Electrode, Foramen Ovale Depth Electrodes, Wyler Sphenoidal Depth ElectrodesAd-Tech Medical Instrument Corp200611—
+5K250363Depth Electrode (RSDE-08); Depth Electrode (RSDE-10); Depth Electrode (RSDE-12); Depth…Beijing Sinovation Medical Technology Co., Ltd.20250—
+5K223269Spencer Probe Depth ElectrodesAd-Tech Medical Instrument Corporation20230—
+5K202087DIXI Medical Microdeep Micro-Macro Depth ElectrodesDixi Medical20210—
+5K201678iCE-SG Subcutaneous Electrode ArraysIce Neurosystems, Inc.20211—
+5K170959DIXI Medical Microdeep Depth ElectrodeDixi Medical201759
+6K213170SENSOSEEG Depth ElectrodesSensomedical Labs, Ltd.20231—
+6K222706iCE-SG2 Subcutaneous Electrode KitIce Neurosystems, Inc.20220—
+6K211367Evo sEEG SystemNeuroone Medical Technologies Corp.20212—
+7K253970Wovyn Depth ElectrodeSensomedical Labs, Ltd.20260—
+7K222404Evo® sEEG SystemNeuroone Medical Technologies Corp.20221—