510(k) Report

Devices descending from K921690

162 later devices reach Flexible Fiberoptic Sigmoidoscope System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K964131EndoscopeAkos Biomedical, Inc.19970—
+1K963795Vision-Sciences Model B-F100 Bronchoscope with Model BS-F21 Disposable EndosheathVision-Sciences, Inc.1996158—
+1K964100Vision-Sciences Model SS-U32 Endo Sheath for Use with the Vsi S-F100 Flexible Fiberoptic…Vision-Sciences, Inc.19960—
+1K963344Disposable SS-F32 Endosheath for Use with the S-F100 Flexible Fiberoptic SigmoidoscopeVision-Sciences, Inc.19962—
+2K061663Endomedical Technologies Quik-Cover Flexible Endoscope Barrier Sheath for…Rtc Inc.-Memcath Technologies, LLC20060—
+2K061324Emt Quik-Cover Flexible Endoscope Barrier Sheath, Series 1-7Rtc Inc.-Memcath Technologies, LLC20060—
+2K021344B-F200 Bronchoscope with BSS-F21 Endosheath SystemVision-Sciences, Inc.2002157—
+3K091768Video Sciences BRS-5000 Video Bronchoscope with Endosheath System, Dpu-5000/Dpu-5050…Vision-Sciences, Inc.200966—
+3K040215Vision-Sciences CST-2000 Flexible Cystoscope with Slide-on Endosheath SystemVision-Sciences, Inc.200426—
+3K032688Colonosight Model 510BSightline Technologies, Ltd.200438—
+3K031786Tne-2000 Esophagoscope with Ecs-D Endosheath SystemVision-Sciences, Inc.200392—
+3K024095Modification to Vision Sciences Endosheath SystemVision-Sciences, Inc.200331—
+4K181292PrimeSight™ UNITY 9000 Video Processor, PrimeSight™ UNITY 9100 Video ProcessorCogentix Medical, Inc.20180—
+4K130845Ambu Ascope 3 5.0/2.2; Ambu Ascope 3 Slim 3.8/1.2; Ambu AviewAmbu A/S201364—
+4K100624Invendo C20 Colonoscopy SystemInvendo Medical Gbmh20126—
+4K100966Colonoscope/Sigmoidoscope SheathesSheathing Technologies, Inc.20101—
+4K091305ClearpathEasyglide, Ltd.200913—
+4K082569Entellus Medical Flexible Endoscope and EyepieceEntellus Medical, Inc.20085—
+4K081004Protectiscope CS Colonoscope, Non-IntrapullStryker GI20089—
+4K072180Vision-Sciences CST-5000 Video Cystoscope with Endosheath SystemVision-Sciences, Inc.200720—
+4K071127Flexible Hysteroscope with Endosheath SystemVision-Sciences, Inc.20075—
+4K072073Vision-Sciences Ent-5000 and Ent-5100 Video Ent Scope with Endosheath System…Vision-Sciences, Inc.200729—
+4K072088Flexible Trans-Nasal Video Esophagoscope with Digital Video Processor and Disposable…Vision-Sciences, Inc.200770—
+4K070622Neoguide Endoscopy SystemNeoguide Systems, Inc.200712—
+4K071903Endosheath Systems for Use with Vision-Sciences Tne ScopeVision-Sciences, Inc.20073—
+4K053560Modified Endosheath System for Vsi Flexible CystoscopeVision-Sciences, Inc.200623—
+4K052930Navigator Endoscopy SystemNeoguide Systems, Inc.200613—
+4K051972Karl Storz Trans-Nasal EsophagoscopeKARL STORZ Endoscopy-America, Inc.20052—
+4K031790Slide-on Endosheath System for Sensory TestingVision-Sciences, Inc.20030—
+5K260503Triton 1 SystemNeptune Medical, Inc.20260—
+5K253905PrimeSight UltraView SystemCogentix Medical, Inc.20260—
+5K223072PENTAX Medical Video Esophagoscope EE17-J10Pentax of America, Inc.20220—
+5K192523CMOS Video Esophagoscope SSUKarl Storz SE & CO. KG20200—
+5K183171ScopeSeal Duodenoscope Protective DeviceGi Scientific, LLC20190—
+5K183256GlideScope BFlex Single-Use Bronchoscope SystemVerathon Medical (Canada) Ulc20196—
+5K181909Luminelle DTx Hysteroscopy SystemUvision360, Inc.20183—
+5K162330Flex Robotic System and Flex Colorectal DriveMedrobotics Corporation201712
+5K1629163NT endoscopy system3nt Medical, Ltd.20173—
+5K161656Ambu 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—
+5K161355invendoscopy E200 SystemInvendo Medical GmbH20161—
+5K160766Ambu USR, Ambu MAmbu A/S201614—
+5K161791Aer-O-Scope Colonoscope SystemGi View, Ltd.20160—
+5K152466Neo-Bronchoscope -Digital Video Bronchoscopy System (Rigid/Flexible)Prosurg, Inc.20160—
+5K150776Medrobotics Flex SystemMedrobotics Corporation20151—
+5K141286Aer-O-Scope Colonoscope SystemGi View, Ltd.20142—
+5K122134Flexlite CameraSpine View, Inc.20120—
+5K121582Invendo C25 Colonoscopy SystemInvendo Medical Gbmh20125—
+5K120289Peerscope SystemPeermedical20126—
+5K112318Clearpath 24Promedic, Inc.20120—
+5K120702E.G. Scan II Esphagoscope SystemIntromedic Co., Ltd.20121—
+5K113050Clearpath Lower GIEasyglide, Ltd.20128—
+5K111030E.G. Scan (TM) Esophagoscope SystemIntromedic Co., Ltd.20112—
+5K102733Vision-Sciences Ent-5000 Video Ent Scope with Endosheath Technology, Vision-Sciences…Vision-Sciences, Inc.20117—
+5K102366Finess EndoscopeEntellus Medical, Inc.20110—
+5K101094ClearjetEasyglide, Ltd.20100—
+5K093779Clearpath UgiEasyglide, Ltd.201010—
+5K082038Clarus Video Airway Endoscope, Models 30000-V and 30003-VClarus Medical, LLC20090—
+5K080622Entity Nasoview Led Nasopharyngoscope, Model 006105Optim, Inc.200815—
+6K220004Zsquare ENT-Flex EndoscopeZsquare, Ltd.20220—
+6K211947GlideScope BFlex 2.8 Single-Use BronchoscopeVerathon Medical (Canada) Ulc20213—
+6K202727Peregrine Endoscopy System3nt Medical, Ltd.20210—
+6K193095Ambu aScope 4 CystoAmbu A/S202013—
+6K192305Colibri Endoscopy System3nt Medical, Ltd.20200—
+6K193488GlideScope BFlex 3.8 Single-Use BronchoscopeVerathon Medical (Canada) Ulc20204—
+6K190669EndoticsEra Endoscopy S.R.L.20200—
+6K191948GlideScope BFlex 5.8 Single-Use BronchoscopeVerathon Medical (Canada) Ulc20195—
+6K190827Luminelle DTx Hysteroscopy System, Luminelle 360 Rotatable Sterile Disposable Sheath RigidUvision360, Inc.20192—
+6K173727Ambu aScope 3 Slim 3.8/1.2 and Ambu aScope 4 Broncho Slim 3.8/1.2; Ambu aScope 3 Regular…Ambu A/S201839—
+6K173085invendoscopy E210 SystemInvendo Medical GmbH20180—
+6K170453Medrobotics Flex Robotic SystemMedrobotics Corporation20170—
+6K172036Medrobotics Flex Robotic SystemMedrobotics Corporation20170—
+6K160015Pure VuMotus GI Medical Technologies, Ltd.20167—
+6K150248ORL Video NasoPharyngo-LarngoscopeJedmed Instrument Company20150—
+6K131131E.G. Scan (TM) II Esophagoscope SystemIntromedic Co., Ltd.20130—
+6K130718Peerscope SystemPeermedical, Ltd.20135—
+6K123359OVS1 Video SystemOlive Medical Corp.20121—
+6K113166Clearpath Upper GIEasyglide, Ltd.20120—
+6K100577Acclarent Cyclops Multi-Angle EndoscopeAcclarent, Inc.20114—
+6K091829PLS Portable Light SourceOptim, Inc.20099—
+7K260420LoopView® Single-Use Digital Flexible Bronchoscope (B27-C, B27-CG)MacroLux Medical Technology Co., Ltd.20260—
+7K251894Himaging Bronchscope SystemHimaging Technology (Shanghai) Co., Ltd.20250—
+7K251140Zenflow Spring ScopeZenflow, Inc.20250—
+7K251823UE BRONCHO Single-Use Bronchoscopes (EBS-380C); UE BRONCHO Single-Use Bronchoscopes…Zhejiang UE Medical Corp.20250—
+7K250232Vathin® Video Bronchoscope SystemHunan Vathin Medical Instrument Co., Ltd.20250—
+7K242793Insighters™ Single-use Bronchoscope/Insight Bimodel-Integral iS-B12A 4.6/2.0…Shenzhen Insighters Medical Technology Co., Ltd.20250—
+7K242535Single-use Flexible Cystoscope (CY-E2E01, CY-E2E01R, CY-E2F01, CY-E2F01R, CY-E2G01…Hunan Vathin Medical Instrument Co., Ltd.20240—
+7K240849Ambu® aScope™ 5 Cysto HD (Standard Deflection); Ambu® aScope™ 5 Cysto HD (Reverse…Ambu A/S20240—
+7K240227LiNA CystoVu™ HD (CYV-100-5; CYV-101-5); LiNA ScopeVu™ (SCP-100-1)Lina Medical Aps20240—
+7K234113MiiS Horus Bronchoscope; MiiS Horus Endoscope Display System -Tablet; MiiS Horus…Medimaging Integrated Solution, Inc (Miis)20240—
+7K233779LoopView® Single-Use Digital Flexible Bronchoscope (B38, B38-C, B50, B50-C, B58, B58-C)…MacroLux Medical Technology Co., Ltd.20240—
+7K231118Cystoscope SystemShenzhen HugeMed Medical Technical Development Co., Ltd.20230—
+7K223926VersaVue Single-Use Flexible Cystoscope, VersaVue Tablet, and VersaVue Video BoxMedimaging Integrated Solution, Inc (Miis)20230—
+7K230948BFlex™ 2 Slim 3.8 Single-Use BronchoscopeVerathon Medical (Canada) Ulc20232—
+7K222910Bronchoscope SystemShenzhen HugeMed Medical Technical Development Co., Ltd.20230—
+7K213235PENTAX Medical ONE Pulmo Single Use Video Bronchoscope SystemPentax of America, Inc.20221—
+7K221580Single-Use Flexible CystoscopeHunan Vathin Medical Instrument Co., Ltd.20220—
+7K222162Flexible Cystoscope (Model: CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US)Shanghai AnQing Medical Instrument Co., Ltd.20221—
+7K222602Pusen Single Use Flexible Video Cystoscope System (Single Use Flexible Video Cystoscope…Zhuhai Pusen Medical Technology Co., Ltd.20221—
+7K220606Ambu aScope 5 Broncho HD 5.6/2.8, Ambu aScope 5 Broncho HD 5.0/2.2, Ambu aBox 2Ambu A/S202210—
+7K213782Single-Use Video Bronchoscopes, Digital ControllerMicro-Tech (Nanjing) Co., Lts20220—