510(k) Report

Devices descending from K173760

7 later devices reach Monarch Endoscopy Platform (Monarch Platform) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K223144Galaxy SystemNoah Medical Corp.202305
+1K193534Monarch PlatformAuris Health, Inc.202054
+2K231473Monarch BronchoscopeAuris Health, Inc., A Johnson and Johnson Family Company202301
+2K211493Monarch PlatformAuris Health, Inc.202122
+2K203614Monarch BronchoscopeAuris Health, Inc., A Johnson and Johnson Family Company20211—
+3K243219MONARCH™ Platform (MON-000008)Auris Health, Inc.202511
+4K260382MONARCH™ Platform (MON-000008)Auris Health, Inc.20260—