510(k) Report

Devices descending from K171306

7 later devices reach gammaCore-S through their predicates, nearest generation first.

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