510(k) Report

Devices descending from K191186

4 later devices reach Subdural Strip/Intraoperative Split Electrode, Subdural Grid/Intraoperative… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K242618Layer 7-TPrecision Neuroscience, Corp.20250—
+1K221123WISE Cortical Strip (WCS)Wise S.R.L.20220—
+1K211954Subdural Electrode, Strip/Intraoperative Strip, Grid/Intraoperative Grid, Multi-Strip…Spes Medica Srl20220—
+1K201931Dixi Medical Intraoperative Subdural Electrodes (Strips and Grids)Dixi Medical20210—