510(k) Report

Devices descending from K031786

92 later devices reach Tne-2000 Esophagoscope with Ecs-D Endosheath System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K082569Entellus Medical Flexible Endoscope and EyepieceEntellus Medical, Inc.20085—
+1K072088Flexible Trans-Nasal Video Esophagoscope with Digital Video Processor and Disposable…Vision-Sciences, Inc.200770—
+1K071903Endosheath Systems for Use with Vision-Sciences Tne ScopeVision-Sciences, Inc.20073—
+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—
+1K053560Modified Endosheath System for Vsi Flexible CystoscopeVision-Sciences, Inc.200623—
+1K051972Karl Storz Trans-Nasal EsophagoscopeKARL STORZ Endoscopy-America, Inc.20052—
+1K040215Vision-Sciences CST-2000 Flexible Cystoscope with Slide-on Endosheath SystemVision-Sciences, Inc.200426—
+2K223072PENTAX Medical Video Esophagoscope EE17-J10Pentax of America, Inc.20220—
+2K192523CMOS Video Esophagoscope SSUKarl Storz SE & CO. KG20200—
+2K181292PrimeSight™ UNITY 9000 Video Processor, PrimeSight™ UNITY 9100 Video ProcessorCogentix Medical, Inc.20180—
+2K1629163NT endoscopy system3nt Medical, Ltd.20173—
+2K120702E.G. Scan II Esphagoscope SystemIntromedic Co., Ltd.20121—
+2K111030E.G. Scan (TM) Esophagoscope SystemIntromedic Co., Ltd.20112—
+2K102366Finess EndoscopeEntellus Medical, Inc.20110—
+2K091768Video Sciences BRS-5000 Video Bronchoscope with Endosheath System, Dpu-5000/Dpu-5050…Vision-Sciences, Inc.200966—
+2K072180Vision-Sciences CST-5000 Video Cystoscope with Endosheath SystemVision-Sciences, Inc.200720—
+2K071127Flexible Hysteroscope with Endosheath SystemVision-Sciences, Inc.20075—
+3K253905PrimeSight UltraView SystemCogentix Medical, Inc.20260—
+3K220004Zsquare ENT-Flex EndoscopeZsquare, Ltd.20220—
+3K202727Peregrine Endoscopy System3nt Medical, Ltd.20210—
+3K192305Colibri Endoscopy System3nt Medical, Ltd.20200—
+3K181909Luminelle DTx Hysteroscopy SystemUvision360, Inc.20183—
+3K160766Ambu USR, Ambu MAmbu A/S201614—
+3K130845Ambu Ascope 3 5.0/2.2; Ambu Ascope 3 Slim 3.8/1.2; Ambu AviewAmbu A/S201364—
+3K131131E.G. Scan (TM) II Esophagoscope SystemIntromedic Co., Ltd.20130—
+4K193095Ambu aScope 4 CystoAmbu A/S202013—
+4K190827Luminelle DTx Hysteroscopy System, Luminelle 360 Rotatable Sterile Disposable Sheath RigidUvision360, Inc.20192—
+4K183256GlideScope BFlex Single-Use Bronchoscope SystemVerathon Medical (Canada) Ulc20196—
+4K161656Ambu 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—
+4K152466Neo-Bronchoscope -Digital Video Bronchoscopy System (Rigid/Flexible)Prosurg, Inc.20160—
+5K251140Zenflow Spring ScopeZenflow, Inc.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—
+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—
+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—
+5K212202WiScope Digital Cystoscope System, WiScope Single-Use Digital Flexible Cystoscope…OTU Medical, Inc.20221—
+5K211947GlideScope BFlex 2.8 Single-Use BronchoscopeVerathon Medical (Canada) Ulc20213—
+5K193488GlideScope BFlex 3.8 Single-Use BronchoscopeVerathon Medical (Canada) Ulc20204—
+5K192278Luminelle DTx Hysteroscopy System, Luminelle Dx 360 Rotatable Disposable Sheath…Uvision360, Inc.20191—
+5K191948GlideScope BFlex 5.8 Single-Use BronchoscopeVerathon Medical (Canada) Ulc20195—
+5K173727Ambu aScope 3 Slim 3.8/1.2 and Ambu aScope 4 Broncho Slim 3.8/1.2; Ambu aScope 3 Regular…Ambu A/S201839—
+6K260420LoopView® Single-Use Digital Flexible Bronchoscope (B27-C, B27-CG)MacroLux Medical Technology Co., Ltd.20260—
+6K251894Himaging Bronchscope SystemHimaging Technology (Shanghai) Co., Ltd.20250—
+6K252598Flexible Cystoscope (CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US)Shanghai AnQing Medical Instrument Co., Ltd.20250—
+6K251823UE BRONCHO Single-Use Bronchoscopes (EBS-380C); UE BRONCHO Single-Use Bronchoscopes…Zhejiang UE Medical Corp.20250—
+6K250232Vathin® Video Bronchoscope SystemHunan Vathin Medical Instrument Co., Ltd.20250—
+6K242793Insighters™ Single-use Bronchoscope/Insight Bimodel-Integral iS-B12A 4.6/2.0…Shenzhen Insighters Medical Technology Co., Ltd.20250—
+6K240283BubbleView™ Single-Use Digital Flexible Cystoscope (C50-C, C50-CR, C50-CB, C50-CBR)…MacroLux Medical Technology Co., Ltd.20240—
+6K234113MiiS Horus Bronchoscope; MiiS Horus Endoscope Display System -Tablet; MiiS Horus…Medimaging Integrated Solution, Inc (Miis)20240—
+6K233779LoopView® Single-Use Digital Flexible Bronchoscope (B38, B38-C, B50, B50-C, B58, B58-C)…MacroLux Medical Technology Co., Ltd.20240—
+6K231702WiScope® Digital Cystoscope System, WiScope® Single-Use Digital Flexible Cystoscope…OTU Medical, Inc.20230—
+6K230948BFlex™ 2 Slim 3.8 Single-Use BronchoscopeVerathon Medical (Canada) Ulc20232—
+6K222910Bronchoscope SystemShenzhen HugeMed Medical Technical Development Co., Ltd.20230—
+6K213235PENTAX Medical ONE Pulmo Single Use Video Bronchoscope SystemPentax of America, Inc.20221—
+6K220606Ambu aScope 5 Broncho HD 5.6/2.8, Ambu aScope 5 Broncho HD 5.0/2.2, Ambu aBox 2Ambu A/S202210—
+6K213782Single-Use Video Bronchoscopes, Digital ControllerMicro-Tech (Nanjing) Co., Lts20220—
+6K220399WiScope Digital Bronchoscope System, WiScope Single-Use Digital Flexible Bronchoscope…OTU Medical, Inc.20220—
+6K211169Bronchoscope SystemShanghai AnQing Medical Instrument Co., Ltd.20212—
+6K211030EXALT Model B Single-Use Bronchoscope (Slim), EXALT Model B Single-Use Bronchoscope…Boston Scientific Corporation20211—
+6K210512LUMINELLE DTx SystemUvision360, Inc.20210—
+6K210883aScope 4 Broncho Regular Sampler Set 5.0/2.2, aScope 4 Broncho Large Sampler Set 5.8/2.8Ambu A/S20212—
+6K202180Broncoflex Agile; Product Reference: 20030001 , Broncoflex Vortex; Product Reference…Axess Vision Technology20201—
+6K191828Vathin Video Bronchoscope SystemHunan Vathin Medical Instrument Co., Ltd.20208—
+7K261637Single-use Flexible BronchoscopeHunan Vathin Medical Instrument Co., Ltd.20260—
+7K243497Portable Video Processor (EA101), Flexible Bronchoscope BS41H-12EU, BS41H-12US…Shanghai AnQing Medical Instrument Co., Ltd.20251—
+7K243541LumiRex BronchoscopeContra Healthcare Solutions, LLC20250—
+7K242010Bronchoscope System, The Single-use Bronchoscope (Single-use Bronchoscope: SP-Y-ZQGJ2.8…Shenzhen Sanping Image Technology Co., Ltd.20250—
+7K242416Single-use Flexible Bronchoscope: BC-E1C10, BC-E1C11, BC-E1C12, BC-E1E10, BC-E1E11…Hunan Vathin Medical Instrument Co., Ltd.20250—
+7K241612Video Bronchoscope System; Single-use Flexible Bronchoscope (BC-S1E00-L, BC-S1H00-L…Hunan Vathin Medical Instrument Co., Ltd.20240—
+7K231107Bronchoscope SystemHunan Endoso Life Technology Co., Ltd.20241—
+7K231970PENTAX Medical Single Use Video Bronchoscope EB11-S01, PENTAX Medical Single Use Video…Pentax of America, Inc.20240—
+7K230428Ambu® aScope™ 5 Broncho 2.7/1.2, Ambu® aScope™ 5 Broncho 4.2/2.2, Ambu® aBox™ 2Ambu A/S20234—
+7K223299Ambu® aScope™ 5 Broncho HD 5.0/2.2, Ambu® aScope™ 5 Broncho HD 5.6/2.8, Ambu® aView™ 2…Ambu A/S202361
+7K223782Ambu aScope 5 Broncho HD 5.6/2.8 Sampler Set, Ambu aScope 5 Broncho HD 5.0/2.2 Sampler SetAmbu A/S20230—
+7K222014EXALT Model B Single-Use BronchoscopeBoston Scientific Corporation20220—
+7K212886Broncoflex Agile, Broncoflex Vortex, ScreeniAxess Vision Technology20220—
+7K210379Broncho Videoscope SystemScivita Medical Technology Co., Ltd.20213—
+7K202346SPiN Vision Video Bronchoscope SystemVeran Medical Technologies, Inc.20210—
+8K253184Video Rhinolaryngoscope System (Disposable Video Rhinolaryngoscope SP11A Endoscopic…Zhuhai Wesee Meditech Co., Ltd.20260—
+8K251752Flexible Bronchoscope (BS27U-12EU, BS27U-12US, BS38U-20EU, BS38U-20US)Shanghai AnQing Medical Instrument Co., Ltd.20250—
+8K250210Broncho Videoscope System (Single-use Broncho Videoscope (SBV-1A-B, SBV-1A-P, SBV-1B-B…Scivita Medical Technology Co., Ltd.20250—
+8K240289Full HD Endoscopic Image Processor (HDVS-S200A, HDVS-S200B, HDVS-S200C, HDVS-S200D)Scivita Medical Technology Co., Ltd.20240—
+8K233671Ambu® aScope™ 5 Broncho 4.2/2.2; Ambu® aScope™ 5 Broncho 2.7/1.2; Ambu® aView™ 2 AdvanceAmbu A/S20242—
+8K231521Broncho Videoscope SystemScivita Medical Technology Co., Ltd.20231—
+8K232582Ambu® aScope™ 5 Broncho 4.2/2.2 Sampler SetAmbu A/S202311
+9K260309Ambu® aScope™ 5 Broncho 2.7/1.2; Ambu® aScope™ 5 Broncho 4.2/2.2; Ambu® aScope™ 5…Ambu A/S20260—
+9K242108Ambu® aScope™ 5 Uretero (Standard Deflection); Ambu® aScope™ 5 Uretero (Reverse…Ambu A/S20240—