510(k) Report

Devices descending from K200723

2 later devices reach StealthStation FlexENT (9736242), StealthStation S8 ENT Software (9735762) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K253395Stealth AXiS™ ENT clinical applicationMedtronic Navigation, Inc.20260—
+1K223734ENT EMBrainlab AG20230—