510(k) Report

Devices descending from K093310

7 later devices reach Gem Flow Coupler Device and System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K191252Gem FlowCoupler SystemBaxter/ Synovis Micro Companies Alliance, Inc.201913
+1K142309GEM Flow COUPLER Device and SystemSynovis Life Technologies, Inc.20143—
+1K132727Gem Flow Coupler Device and SystemSynovis Life Technologies, Inc.201345
+2K213974GEM FLOW COUPLER Monitor (GEM1020M-2)Synovis Micro Companies Alliance, Inc.20220—
+2K143589GEM Flow COUPLER Device and SystemSynovis Life Technologies, Inc.201522
+3K233394Gem Flow Now (GEM2770-FN)Synovis Micro Companies Alliance20240—
+3K190499Gem FlowCoupler SystemBaxter/ Synovis Micro Companies Alliance, Inc.20190—