510(k) Report

Devices descending from K021144

10 later devices reach Subdural Strip Electrode through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K053363Dual-Sided Interhemispheric Subdural Electrodes, Grid Subdural Electrodes…Ad-Tech Medical Instrument Corp20069Class I
+2K221123WISE Cortical Strip (WCS)Wise S.R.L.20220—
+2K191346Blackrock NeuroCoG Subdural Cortical Electrodes (Strips and Grids)Blackrock Microsystems20200—
+2K191186Subdural Strip/Intraoperative Split Electrode, Subdural Grid/Intraoperative Grid…Ad-Tech Medical Instrument Corporation20204—
+2K183437AirRay Subdural Cortical ElectrodesCortec GmbH20190—
+2K082474PMT Subdural Cortical ElectrodesPmt Corp.20091—
+3K242618Layer 7-TPrecision Neuroscience, Corp.20250—
+3K211954Subdural Electrode, Strip/Intraoperative Strip, Grid/Intraoperative Grid, Multi-Strip…Spes Medica Srl20220—
+3K201931Dixi Medical Intraoperative Subdural Electrodes (Strips and Grids)Dixi Medical20210—
+3K192764NeuroOne Cortical ElectrodeNeuroone, Inc.20190—