510(k) Report

Devices descending from K161347

5 later devices reach Signia sterilization tray through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K192781UroLift System Procedure Kit Sterilization TrayNeotract, Inc.20201—
+1K180915Sonicision Reusable Sterilization TrayCovidien20181—
+1K170226iTotal Family Reusable Instrument TrayConformis, Inc.20170—
+2K243589PAL Sterilization CaseMicroaire Surgical Instruments, LLC20250—
+2K212396UroLift System Rigid Retrieval Kit Sterilization TrayNeotract, Inc.20210—