510(k) Report

Devices descending from K021344

157 later devices reach B-F200 Bronchoscope with BSS-F21 Endosheath System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K202180Broncoflex Agile; Product Reference: 20030001 , Broncoflex Vortex; Product Reference…Axess Vision Technology20201—
+5K191828Vathin Video Bronchoscope SystemHunan Vathin Medical Instrument Co., Ltd.20208—
+5K192278Luminelle DTx Hysteroscopy System, Luminelle Dx 360 Rotatable Disposable Sheath…Uvision360, Inc.20191—
+5K173392Pure-Vu SystemMotus GI Medical Technologies, Ltd.20176—
+5K1525138X-10-XXXX Camera SystemSanta Barbara Imaging Systems20150—
+5K133311EndoledOlympus Winter & Ibe GmbH20140—
+5K133941Mitek ArthroscopesMedos International SARL20140—
+5K132839Fuse 1C Colonoscopy SystemEndochoice, Inc.20142—
+5K131422Peerscope SystemEndochoice, Inc.20132—
+5K130503Pathassist Led Light FiberEntellus Medical, Inc.20136—
+5K110097Acclarent Cyclops Multi-Angle EndoscopeAcclarent, Inc.20113—
+5K100125Vision Sciences Flexible Ent ScopeVision-Sciences, Inc.201002
+6K261637Single-use Flexible BronchoscopeHunan Vathin Medical Instrument Co., Ltd.20260—
+6K252598Flexible Cystoscope (CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US)Shanghai AnQing Medical Instrument Co., Ltd.20250—
+6K243497Portable Video Processor (EA101), Flexible Bronchoscope BS41H-12EU, BS41H-12US…Shanghai AnQing Medical Instrument Co., Ltd.20251—
+6K243541LumiRex BronchoscopeContra Healthcare Solutions, LLC20250—
+6K242010Bronchoscope System, The Single-use Bronchoscope (Single-use Bronchoscope: SP-Y-ZQGJ2.8…Shenzhen Sanping Image Technology Co., Ltd.20250—
+6K242416Single-use Flexible Bronchoscope: BC-E1C10, BC-E1C11, BC-E1C12, BC-E1E10, BC-E1E11…Hunan Vathin Medical Instrument Co., Ltd.20250—
+6K241612Video Bronchoscope System; Single-use Flexible Bronchoscope (BC-S1E00-L, BC-S1H00-L…Hunan Vathin Medical Instrument Co., Ltd.20240—
+6K240283BubbleView™ Single-Use Digital Flexible Cystoscope (C50-C, C50-CR, C50-CB, C50-CBR)…MacroLux Medical Technology Co., Ltd.20240—
+6K231107Bronchoscope SystemHunan Endoso Life Technology Co., Ltd.20241—
+6K231970PENTAX Medical Single Use Video Bronchoscope EB11-S01, PENTAX Medical Single Use Video…Pentax of America, Inc.20240—
+6K231702WiScope® Digital Cystoscope System, WiScope® Single-Use Digital Flexible Cystoscope…OTU Medical, Inc.20230—
+6K230428Ambu® aScope™ 5 Broncho 2.7/1.2, Ambu® aScope™ 5 Broncho 4.2/2.2, Ambu® aBox™ 2Ambu A/S20234—
+6K223299Ambu® aScope™ 5 Broncho HD 5.0/2.2, Ambu® aScope™ 5 Broncho HD 5.6/2.8, Ambu® aView™ 2…Ambu A/S202361
+6K223782Ambu aScope 5 Broncho HD 5.6/2.8 Sampler Set, Ambu aScope 5 Broncho HD 5.0/2.2 Sampler SetAmbu A/S20230—
+6K222014EXALT Model B Single-Use BronchoscopeBoston Scientific Corporation20220—
+6K212886Broncoflex Agile, Broncoflex Vortex, ScreeniAxess Vision Technology20220—
+6K210379Broncho Videoscope SystemScivita Medical Technology Co., Ltd.20213—
+6K210512LUMINELLE DTx SystemUvision360, Inc.20210—
+6K202346SPiN Vision Video Bronchoscope SystemVeran Medical Technologies, Inc.20210—
+6K181437Pure Vu SystemMotus GI Medical Technologies, Ltd.20185—
+6K152182Fuse Gastroscopy SystemEndochoice, Inc.20151—
+6K141598Fuse Colonoscopy SystemEndochoice, Inc.201411
+6K141916Pathassist Led Light FiberEntellus Medical, Inc.20145—
+6K132433Acclarent Cyclops Multi-Angle EndoscopeAcclarent, Inc.20141—
+7K253184Video Rhinolaryngoscope System (Disposable Video Rhinolaryngoscope SP11A Endoscopic…Zhuhai Wesee Meditech Co., Ltd.20260—
+7K251752Flexible Bronchoscope (BS27U-12EU, BS27U-12US, BS38U-20EU, BS38U-20US)Shanghai AnQing Medical Instrument Co., Ltd.20250—
+7K250210Broncho Videoscope System (Single-use Broncho Videoscope (SBV-1A-B, SBV-1A-P, SBV-1B-B…Scivita Medical Technology Co., Ltd.20250—
+7K240289Full HD Endoscopic Image Processor (HDVS-S200A, HDVS-S200B, HDVS-S200C, HDVS-S200D)Scivita Medical Technology Co., Ltd.20240—
+7K233671Ambu® aScope™ 5 Broncho 4.2/2.2; Ambu® aScope™ 5 Broncho 2.7/1.2; Ambu® aView™ 2 AdvanceAmbu A/S20242—
+7K231521Broncho Videoscope SystemScivita Medical Technology Co., Ltd.20231—
+7K232582Ambu® aScope™ 5 Broncho 4.2/2.2 Sampler SetAmbu A/S202311
+7K212774VenSure LightGuideIntersect Ent.20221—
+7K191220Pure Vu SystemMotus GI Medical Technologies, Ltd.20194—
+7K153701ULYSS Multi View SinuscopeSopro-Comeg GmbH20160—
+7K160275Fuse Endoscopic System with FuseBox ProcessorEndochoice, Inc.20160—
+7K152435PassAssist LED Light FiberEntellus Medical, Inc.20152—
+8K260309Ambu® aScope™ 5 Broncho 2.7/1.2; Ambu® aScope™ 5 Broncho 4.2/2.2; Ambu® aScope™ 5…Ambu A/S20260—
+8K242108Ambu® aScope™ 5 Uretero (Standard Deflection); Ambu® aScope™ 5 Uretero (Reverse…Ambu A/S20240—
+8K230065VenSure™ Balloon Dilation System, VenSure™ Light Balloon Dilation System, VenSure™ Nav…Fiagon GmbH20230—
+8K230258BB 8 Sinus Dilation KitExcelent, Inc.20230—
+8K220007Pure-Vu EVS SystemMotus GI Medical Technologies, Ltd.20222—
+8K210981Pure Vu SystemMotus GI Medical Technologies, Ltd.20210—
+8K201398SINUSPRIME Dilation SystemStryker Ent20200—
+9K232922Pure-Vu EVS SystemMotus GI Medical Technologies, Ltd.20231—
+10K240853Pathfinder® CR SystemNeptune Medical, Inc.20240—