510(k) Report

Devices descending from K162611

12 later devices reach PeriFLEX through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K173760Monarch Endoscopy Platform (Monarch Platform)Auris Surgical Robotics, Inc.201871
+1K171232PeriView FLEXOlympus Surgical Technologies America20173—
+2K223144Galaxy SystemNoah Medical Corp.202305
+2K221206Compass Steerable NeedleSerpex Medical, Inc.20221—
+2K193534Monarch PlatformAuris Health, Inc.202054
+2K181193PeriView FLEXOlympus Surgical Technologies America20180—
+3K252874Compass Steerable Needle with Adapters SRA-1-01 and SRA-2-01Serpex Medical, Inc.20250—
+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—