510(k) Report

Devices descending from K193534

5 later devices reach Monarch Platform through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K231473Monarch BronchoscopeAuris Health, Inc., A Johnson and Johnson Family Company202301
+1K211493Monarch PlatformAuris Health, Inc.202122
+1K203614Monarch BronchoscopeAuris Health, Inc., A Johnson and Johnson Family Company20211—
+2K243219MONARCH™ Platform (MON-000008)Auris Health, Inc.202511
+3K260382MONARCH™ Platform (MON-000008)Auris Health, Inc.20260—