510(k) Report

Devices descending from DEN150048

8 later devices reach gammaCore Non-invasive Vagus Nerve Stimulator through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K171306gammaCore-SElectrocore, LLC20177—
+2K173442gammaCore-SElectrocore, LLC20180—
+2K172270gammaCore-2Eletrocore, LLC20175—
+3K180538gammaCore SapphireElectrocore, LLC20184—
+4K182369gammaCore SapphireElectrocore, Inc.20183—
+5K191830gammaCore SapphireElectrocore, Inc.20202—
+6K203546gammaCore SapphireElectrocore, Inc.20211—
+7K211856gammaCore SapphireElectrocore, Inc.20210—