510(k) Report

Devices descending from K170018

3 later devices reach StealthStationTM S8 ENT Software through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K200723StealthStation FlexENT (9736242), StealthStation S8 ENT Software (9735762)Medtronic Navigation, Inc.20202—
+2K253395Stealth AXiS™ ENT clinical applicationMedtronic Navigation, Inc.20260—
+2K223734ENT EMBrainlab AG20230—