510(k) Report

Devices descending from K944650

9 later devices reach Wang Bronchial Needle Brush through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K173760Monarch Endoscopy Platform (Monarch Platform)Auris Surgical Robotics, Inc.201871
+1K130357Superdimension Triple-Needle Cytology BrushCovidien, LLC20130—
+2K223144Galaxy SystemNoah Medical Corp.202305
+2K193534Monarch PlatformAuris Health, Inc.202054
+3K231473Monarch BronchoscopeAuris Health, Inc., A Johnson and Johnson Family Company202301
+3K211493Monarch PlatformAuris Health, Inc.202122
+3K203614Monarch BronchoscopeAuris Health, Inc., A Johnson and Johnson Family Company20211—
+4K243219MONARCH™ Platform (MON-000008)Auris Health, Inc.202511
+5K260382MONARCH™ Platform (MON-000008)Auris Health, Inc.20260—