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
+1K091768Video Sciences BRS-5000 Video Bronchoscope with Endosheath System, Dpu-5000/Dpu-5050…Vision-Sciences, Inc.200966—
+1K061663Endomedical Technologies Quik-Cover Flexible Endoscope Barrier Sheath for…Rtc Inc.-Memcath Technologies, LLC20060—
+1K061324Emt Quik-Cover Flexible Endoscope Barrier Sheath, Series 1-7Rtc Inc.-Memcath Technologies, LLC20060—
+1K040215Vision-Sciences CST-2000 Flexible Cystoscope with Slide-on Endosheath SystemVision-Sciences, Inc.200426—
+1K032688Colonosight Model 510BSightline Technologies, Ltd.200438—
+1K031786Tne-2000 Esophagoscope with Ecs-D Endosheath SystemVision-Sciences, Inc.200392—
+1K024095Modification to Vision Sciences Endosheath SystemVision-Sciences, Inc.200331—
+2K181292PrimeSight™ UNITY 9000 Video Processor, PrimeSight™ UNITY 9100 Video ProcessorCogentix Medical, Inc.20180—
+2K130845Ambu Ascope 3 5.0/2.2; Ambu Ascope 3 Slim 3.8/1.2; Ambu AviewAmbu A/S201364—
+2K100624Invendo C20 Colonoscopy SystemInvendo Medical Gbmh20126—
+2K100966Colonoscope/Sigmoidoscope SheathesSheathing Technologies, Inc.20101—
+2K091305ClearpathEasyglide, Ltd.200913—
+2K082569Entellus Medical Flexible Endoscope and EyepieceEntellus Medical, Inc.20085—
+2K081004Protectiscope CS Colonoscope, Non-IntrapullStryker GI20089—
+2K072180Vision-Sciences CST-5000 Video Cystoscope with Endosheath SystemVision-Sciences, Inc.200720—
+2K071127Flexible Hysteroscope with Endosheath SystemVision-Sciences, Inc.20075—
+2K072073Vision-Sciences Ent-5000 and Ent-5100 Video Ent Scope with Endosheath System…Vision-Sciences, Inc.200729—
+2K072088Flexible Trans-Nasal Video Esophagoscope with Digital Video Processor and Disposable…Vision-Sciences, Inc.200770—
+2K070622Neoguide Endoscopy SystemNeoguide Systems, Inc.200712—
+2K071903Endosheath Systems for Use with Vision-Sciences Tne ScopeVision-Sciences, Inc.20073—
+2K053560Modified Endosheath System for Vsi Flexible CystoscopeVision-Sciences, Inc.200623—
+2K052930Navigator Endoscopy SystemNeoguide Systems, Inc.200613—
+2K051972Karl Storz Trans-Nasal EsophagoscopeKARL STORZ Endoscopy-America, Inc.20052—
+2K031790Slide-on Endosheath System for Sensory TestingVision-Sciences, Inc.20030—
+3K260503Triton 1 SystemNeptune Medical, Inc.20260—
+3K253905PrimeSight UltraView SystemCogentix Medical, Inc.20260—
+3K223072PENTAX Medical Video Esophagoscope EE17-J10Pentax of America, Inc.20220—
+3K192523CMOS Video Esophagoscope SSUKarl Storz SE & CO. KG20200—
+3K183171ScopeSeal Duodenoscope Protective DeviceGi Scientific, LLC20190—
+3K183256GlideScope BFlex Single-Use Bronchoscope SystemVerathon Medical (Canada) Ulc20196—
+3K181909Luminelle DTx Hysteroscopy SystemUvision360, Inc.20183—
+3K162330Flex Robotic System and Flex Colorectal DriveMedrobotics Corporation201712
+3K1629163NT endoscopy system3nt Medical, Ltd.20173—
+3K161656Ambu aScope 3 Regular 5.0/2.2, Ambu aScope 3 Slim 3.8/1.2, Ambu aScope 3 Large 5.8/2.8…Ambu A/S201640—
+3K161355invendoscopy E200 SystemInvendo Medical GmbH20161—
+3K160766Ambu USR, Ambu MAmbu A/S201614—
+3K161791Aer-O-Scope Colonoscope SystemGi View, Ltd.20160—
+3K152466Neo-Bronchoscope -Digital Video Bronchoscopy System (Rigid/Flexible)Prosurg, Inc.20160—
+3K150776Medrobotics Flex SystemMedrobotics Corporation20151—
+3K141286Aer-O-Scope Colonoscope SystemGi View, Ltd.20142—
+3K122134Flexlite CameraSpine View, Inc.20120—
+3K121582Invendo C25 Colonoscopy SystemInvendo Medical Gbmh20125—
+3K120289Peerscope SystemPeermedical20126—
+3K112318Clearpath 24Promedic, Inc.20120—
+3K120702E.G. Scan II Esphagoscope SystemIntromedic Co., Ltd.20121—
+3K113050Clearpath Lower GIEasyglide, Ltd.20128—
+3K111030E.G. Scan (TM) Esophagoscope SystemIntromedic Co., Ltd.20112—
+3K102733Vision-Sciences Ent-5000 Video Ent Scope with Endosheath Technology, Vision-Sciences…Vision-Sciences, Inc.20117—
+3K102366Finess EndoscopeEntellus Medical, Inc.20110—
+3K101094ClearjetEasyglide, Ltd.20100—
+3K093779Clearpath UgiEasyglide, Ltd.201010—
+3K082038Clarus Video Airway Endoscope, Models 30000-V and 30003-VClarus Medical, LLC20090—
+3K080622Entity Nasoview Led Nasopharyngoscope, Model 006105Optim, Inc.200815—
+4K220004Zsquare ENT-Flex EndoscopeZsquare, Ltd.20220—
+4K211947GlideScope BFlex 2.8 Single-Use BronchoscopeVerathon Medical (Canada) Ulc20213—
+4K202727Peregrine Endoscopy System3nt Medical, Ltd.20210—
+4K193095Ambu aScope 4 CystoAmbu A/S202013—
+4K192305Colibri Endoscopy System3nt Medical, Ltd.20200—
+4K193488GlideScope BFlex 3.8 Single-Use BronchoscopeVerathon Medical (Canada) Ulc20204—
+4K190669EndoticsEra Endoscopy S.R.L.20200—
+4K191948GlideScope BFlex 5.8 Single-Use BronchoscopeVerathon Medical (Canada) Ulc20195—
+4K190827Luminelle DTx Hysteroscopy System, Luminelle 360 Rotatable Sterile Disposable Sheath RigidUvision360, Inc.20192—
+4K173727Ambu aScope 3 Slim 3.8/1.2 and Ambu aScope 4 Broncho Slim 3.8/1.2; Ambu aScope 3 Regular…Ambu A/S201839—
+4K173085invendoscopy E210 SystemInvendo Medical GmbH20180—
+4K170453Medrobotics Flex Robotic SystemMedrobotics Corporation20170—
+4K172036Medrobotics Flex Robotic SystemMedrobotics Corporation20170—
+4K160015Pure VuMotus GI Medical Technologies, Ltd.20167—
+4K150248ORL Video NasoPharyngo-LarngoscopeJedmed Instrument Company20150—
+4K131131E.G. Scan (TM) II Esophagoscope SystemIntromedic Co., Ltd.20130—
+4K130718Peerscope SystemPeermedical, Ltd.20135—
+4K123359OVS1 Video SystemOlive Medical Corp.20121—
+4K113166Clearpath Upper GIEasyglide, Ltd.20120—
+4K100577Acclarent Cyclops Multi-Angle EndoscopeAcclarent, Inc.20114—
+4K091829PLS Portable Light SourceOptim, Inc.20099—
+5K260420LoopView® Single-Use Digital Flexible Bronchoscope (B27-C, B27-CG)MacroLux Medical Technology Co., Ltd.20260—
+5K251894Himaging Bronchscope SystemHimaging Technology (Shanghai) Co., Ltd.20250—
+5K251140Zenflow Spring ScopeZenflow, Inc.20250—
+5K251823UE BRONCHO Single-Use Bronchoscopes (EBS-380C); UE BRONCHO Single-Use Bronchoscopes…Zhejiang UE Medical Corp.20250—
+5K250232Vathin® Video Bronchoscope SystemHunan Vathin Medical Instrument Co., Ltd.20250—
+5K242793Insighters™ Single-use Bronchoscope/Insight Bimodel-Integral iS-B12A 4.6/2.0…Shenzhen Insighters Medical Technology Co., Ltd.20250—
+5K242535Single-use Flexible Cystoscope (CY-E2E01, CY-E2E01R, CY-E2F01, CY-E2F01R, CY-E2G01…Hunan Vathin Medical Instrument Co., Ltd.20240—
+5K240849Ambu® aScope™ 5 Cysto HD (Standard Deflection); Ambu® aScope™ 5 Cysto HD (Reverse…Ambu A/S20240—
+5K240227LiNA CystoVu™ HD (CYV-100-5; CYV-101-5); LiNA ScopeVu™ (SCP-100-1)Lina Medical Aps20240—
+5K234113MiiS Horus Bronchoscope; MiiS Horus Endoscope Display System -Tablet; MiiS Horus…Medimaging Integrated Solution, Inc (Miis)20240—
+5K233779LoopView® Single-Use Digital Flexible Bronchoscope (B38, B38-C, B50, B50-C, B58, B58-C)…MacroLux Medical Technology Co., Ltd.20240—
+5K231118Cystoscope SystemShenzhen HugeMed Medical Technical Development Co., Ltd.20230—
+5K223926VersaVue Single-Use Flexible Cystoscope, VersaVue Tablet, and VersaVue Video BoxMedimaging Integrated Solution, Inc (Miis)20230—
+5K230948BFlex™ 2 Slim 3.8 Single-Use BronchoscopeVerathon Medical (Canada) Ulc20232—
+5K222910Bronchoscope SystemShenzhen HugeMed Medical Technical Development Co., Ltd.20230—
+5K213235PENTAX Medical ONE Pulmo Single Use Video Bronchoscope SystemPentax of America, Inc.20221—
+5K221580Single-Use Flexible CystoscopeHunan Vathin Medical Instrument Co., Ltd.20220—
+5K222162Flexible Cystoscope (Model: CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US)Shanghai AnQing Medical Instrument Co., Ltd.20221—
+5K222602Pusen Single Use Flexible Video Cystoscope System (Single Use Flexible Video Cystoscope…Zhuhai Pusen Medical Technology Co., Ltd.20221—
+5K220606Ambu aScope 5 Broncho HD 5.6/2.8, Ambu aScope 5 Broncho HD 5.0/2.2, Ambu aBox 2Ambu A/S202210—
+5K213782Single-Use Video Bronchoscopes, Digital ControllerMicro-Tech (Nanjing) Co., Lts20220—
+5K220399WiScope Digital Bronchoscope System, WiScope Single-Use Digital Flexible Bronchoscope…OTU Medical, Inc.20220—
+5K212202WiScope Digital Cystoscope System, WiScope Single-Use Digital Flexible Cystoscope…OTU Medical, Inc.20221—
+5K211169Bronchoscope SystemShanghai AnQing Medical Instrument Co., Ltd.20212—
+5K211030EXALT Model B Single-Use Bronchoscope (Slim), EXALT Model B Single-Use Bronchoscope…Boston Scientific Corporation20211—
+5K210883aScope 4 Broncho Regular Sampler Set 5.0/2.2, aScope 4 Broncho Large Sampler Set 5.8/2.8Ambu A/S20212—