510(k) Report

Devices descending from K962618

2 later devices reach Gyrex V-EP through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K980306Gyrex 2T Prestige, Gyrex Prima Itg, Gyrex Privilege, Gyrex V-EPElscint, Inc.19980—
+1K9725922T Prestige (100-6321-0107)/Privilege (100-6326-0102)/Gyrex V-EP (100-6327-0101)Elscint, Inc.19970—