510(k) Report

Devices descending from K143589

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K233394Gem Flow Now (GEM2770-FN)Synovis Micro Companies Alliance20240—
+1K190499Gem FlowCoupler SystemBaxter/ Synovis Micro Companies Alliance, Inc.20190—