510(k) Report

Devices descending from K172270

5 later devices reach gammaCore-2 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K180538gammaCore SapphireElectrocore, LLC20184—
+2K182369gammaCore SapphireElectrocore, Inc.20183—
+3K191830gammaCore SapphireElectrocore, Inc.20202—
+4K203546gammaCore SapphireElectrocore, Inc.20211—
+5K211856gammaCore SapphireElectrocore, Inc.20210—