510(k) Report

Devices descending from K961942

2 later devices reach Epidural Peg Electrode (EP), Sphenoidal Electrode (Eds) and Foramen, Ovale… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K201678iCE-SG Subcutaneous Electrode ArraysIce Neurosystems, Inc.20211—
+2K222706iCE-SG2 Subcutaneous Electrode KitIce Neurosystems, Inc.20220—