510(k) Report

Devices descending from K954039

5 later devices reach Gyrex Privilege through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K980306Gyrex 2T Prestige, Gyrex Prima Itg, Gyrex Privilege, Gyrex V-EPElscint, Inc.19980—
+1K974614Gyrex 2T Prestige 100-6321-0107, Gyrex Priviledge 100-6326-0102, Gyrex Prima 1TG…Elscint, Inc.19980—
+1K9725922T Prestige (100-6321-0107)/Privilege (100-6326-0102)/Gyrex V-EP (100-6327-0101)Elscint, Inc.19970—
+1K965044Gyrex 2T Prestige Model NO. 100-6321-0107 and Gyrex Privilege Model NO. 100-6326-0102Elscint, Inc.19970—
+1K962618Gyrex V-EPElscint, Inc.19962—