510(k) Report

Devices descending from K162176

4 later devices reach Fiagon Navigation System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K211291Cube Navigation System, VirtuEye V2, Navigation Sensor NanoRest, Navigation Unit Cube 4DFiagon GmbH20211—
+1K192397TruDi Navigation SystemBiosense Webster202011
+2K261540Cube 4D Navigation System, VirtuEye ProFiagon GmbH20260—
+2K231862TruDi® Navigation System V3 (FG-2000-00)Acclarent, Inc.202301