510(k) Report

Devices descending from K173628

2 later devices reach Acclarent ENT Navigation System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K192397TruDi Navigation SystemBiosense Webster202011
+2K231862TruDi® Navigation System V3 (FG-2000-00)Acclarent, Inc.202301