510(k) Report

Devices descending from K142309

3 later devices reach GEM Flow COUPLER Device and System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K143589GEM Flow COUPLER Device and SystemSynovis Life Technologies, Inc.201522
+2K233394Gem Flow Now (GEM2770-FN)Synovis Micro Companies Alliance20240—
+2K190499Gem FlowCoupler SystemBaxter/ Synovis Micro Companies Alliance, Inc.20190—