510(k) Report

Devices descending from K071530

26 later devices reach Karl Storz Video Flexible Video Ent Endoscope System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K212656Flexible Intubation Video Endoscope – Sterile (FIVE-S)Karl Storz Endoscopy America202112
+1K173760Monarch Endoscopy Platform (Monarch Platform)Auris Surgical Robotics, Inc.201871
+1K152319Auris Robotic Endoscopy System (ARES)Auris Surgical Robotics, Inc.20160—
+1K141366Video Bronchoscope SystemScholly Fiberoptic GmbH201413—
+1K082038Clarus Video Airway Endoscope, Models 30000-V and 30003-VClarus Medical, LLC20090—
+2K251731KARL STORZ Flexible Intubation Video Endoscope – Sterile (FIVE-S) (0916612)Karl Storz SE & CO. KG20250—
+2K223144Galaxy SystemNoah Medical Corp.202305
+2K193534Monarch PlatformAuris Health, Inc.202054
+2K182188Ion Endoluminal System ; Flexision Biopsy NeedleIntuitive Surgical2019125
+3K231473Monarch BronchoscopeAuris Health, Inc., A Johnson and Johnson Family Company202301
+3K221206Compass Steerable NeedleSerpex Medical, Inc.20221—
+3K211493Monarch PlatformAuris Health, Inc.202122
+3K203614Monarch BronchoscopeAuris Health, Inc., A Johnson and Johnson Family Company20211—
+3K202370Ion Endoluminal SystemIntuitive Surgical, Inc.20205—
+3K192367Ion Endoluminal SystemIntuitive Surgical, Inc.20193—
+4K252874Compass Steerable Needle with Adapters SRA-1-01 and SRA-2-01Serpex Medical, Inc.20250—
+4K243219MONARCH™ Platform (MON-000008)Auris Health, Inc.202511
+4K220299Ion Endoluminal System (IF1000)Intuitive Surgical, Inc.20224—
+4K201146Ion Endoluminal SystemIntuitive Surgical, Inc.20202—
+5K260382MONARCH™ Platform (MON-000008)Auris Health, Inc.20260—
+5K232984Ion Endoluminal System (IF1000)Intuitive Surgical, Inc.20233—
+5K212048Ion Endoluminal System (Ion Fully Articulating Catheter), Ion Endoluminal System (Ion…Intuitive Surgical, Inc.202111
+6K242070Ion Endoluminal System (IF 1000)Intuitive Surgical, Inc.20242—
+6K240135Ion™ Endoluminal System (Ion™ Fully Articulating Catheter) (IF1000)Intuitive Surgical, Inc.20240—
+7K252045Ion Endoluminal System (IF1000)Intuitive Surgical, Inc.20250—
+7K252528Ion Endoluminal System (IF1000)Intuitive Surgical, Inc.20250—