510(k) Report

Devices descending from K163355

5 later devices reach Depth Electrodes, Foramen Ovale Depth Eletrodes, Marco-Micro Depth Electrodes… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K250363Depth Electrode (RSDE-08); Depth Electrode (RSDE-10); Depth Electrode (RSDE-12); Depth…Beijing Sinovation Medical Technology Co., Ltd.20250—
+1K223269Spencer Probe Depth ElectrodesAd-Tech Medical Instrument Corporation20230—
+1K202087DIXI Medical Microdeep Micro-Macro Depth ElectrodesDixi Medical20210—
+1K201678iCE-SG Subcutaneous Electrode ArraysIce Neurosystems, Inc.20211—
+2K222706iCE-SG2 Subcutaneous Electrode KitIce Neurosystems, Inc.20220—