510(k) Report

Devices descending from K972926

102 later devices reach MVM 7.5 French Flexible Choledochoscope through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K023358Usa Series Dur 8 Elite, Usa Series Dur 8, Models Dur 8E, Dur 8Acmi Corporation2003101—
+2K111480Maxiflex - Semi Flex Scope, 25 to 65 CMTechnology Delivery Systems, Inc.20120—
+2K060269Acmi Dur-Digital Ureteroscope and Choledochoscope SystemAcmi Corporation200699—
+3K210579WiScope OM Endoscope System, WiScope Single-Use Digital Flexible…OTU Medical, Inc.20211—
+3K153049LithoVue SystemBoston Scientific Corporation201524—
+3K142922SpyGlass DS Direct Visualization SystemBoston Scientific Corporation201591
+3K142556Flexible Video-Uretero-Choledochoscope SystemKARL STORZ Endoscopy-America, Inc.20147—
+3K131369Flexible Video-Uretero-Renoscope SystemKARL STORZ Endoscopy-America, Inc.2013531
+3K092278Gyrus Acmi Invisio Digital Hysteroscope, Model Idh-4Gyrus Acmi, Inc.200922—
+3K072594Gyrus Acmi Ipn-2505, Invisio Smith Percutaneous Nephroscope SystemGyrus Acmi, Inc.200723—
+4K254153Single-use Video Scope; PB Digital ControllerMirco-Tech (Nanjing) Co., Ltd.20260—
+4K241444Biliary Pancreaticobiliary Scope SystemShenzhen HugeMed Medical Technical Development Co., Ltd.20250—
+4K233630Ambu® aScope™ 5 Uretero (Standard Deflection); Ambu® aScope™ 5 Uretero (Reverse…Ambu A/S20241—
+4K233275RenaFlex Single-use Flexible Ureteroscope (SUURF-V Standard); RenaFlex Single-use…Gyrus Acmi, Inc.20240—
+4K231497Choledochoscope SystemShenzhen HugeMed Medical Technical Development Co., Ltd.20240—
+4K223097RenaNav Ureteroscope SystemCenterPoint Systems, LLC20230—
+4K221784Single-use Video Pancreaticobiliary Scope, PB Digital ControllerMicro-Tech (Nanjing) Co., Ltd.20232—
+4K221515StoneSmart Connect Console, LithoVue Elite Single Use Digital Flexible Ureteroscope…Boston Scientific Corporation20234—
+4K213334Monarch Platform, UrologyAuris Health, Inc.202201
+4K211686Flexible Video-Choledo-Cysto-Ureteroscope SystemShanghai SeeGen Photoelectric Technology Co., Ltd.20222—
+4K211347Uretero1 Ureteroscope SystemSTERIS Corporation20213—
+4K200483SpyGlass Discover Digital Catheter, SpyGlass Discover Digital ControllerBoston Scientific Corporation20203—
+4K183188Flexible Sensor-Ureterorenoscopes BOA Vision EF, Flexible Sensor-Ureterorenoscopes COBRA…Richard Wolf Medical Instruments Corporation20191—
+4K181439SpyGlass DS and DS II Direct Visualization SystemBoston Scientific Corporation20187—
+4K180367Ureterorenoscope SystemShanghai AnQing Medical Instrument Co., Ltd.20189—
+4K171113LiNA OperaScope with HDMI cable and on-board LCD-single unit, LiNA OperaScope with HDMI…Lina Medical Aps20184—
+4K172098Medical Video Endoscope SystemZhuhai Pusen Medical Technology Co., Ltd.201723—
+4K171076Medical Video Endoscope SystemZhuhai Pusen Medical Technology Co., Ltd.20174—
+4K141250Flexible Video-Uretero-Renoscope SystemKARL STORZ Endoscopy-America, Inc.2014112
+4K123151Endosee Model 8000 U-ScopeEndosee Corp201320—
+4K093218Femeye TwoFem Suite, LLC20100—
+5K260516BubbleView Single-Use Digital Flexible Cystoscope (C38-CS, C38-CRS, C50-C, C50-CR…MacroLux Medical Technology Co., Ltd.20260—
+5K252492Visualized Access and Delivery Catheter; PB Digital ControllerMicro-Tech (Nanjing) Co., Ltd.20260—
+5K252468Single-use Digital Flexible Ureteroscope (GY-UR9.3); Single-use Digital Flexible…Zhejiang Geyi Medical Instrument Co., Ltd.20250—
+5K250049Medical Video Endoscope [Standard Deflection] (URS3005); Medical Video Endoscope…Seplou (Zhuhai) Co., Ltd.20250—
+5K243550KARL STORZ Flexible Video-Uretero-Renoscope (FLEX XC)Karl Storz SE & CO. KG20250—
+5K250785Single-use Flexible UreteroscopeHunan Vathin Medical Instrument Co., Ltd.20250—
+5K243894F88 URE-SD/RD Flexible UreteroscopeSg Endoscopy Pte, Ltd.20250—
+5K243532LumiRex UreteroscopeContra Healthcare Solutions, LLC20250—
+5K243708Urology Videoscope System (Single-use Flexible Ureteroscope: SUV-1A-B, SUV-1A-P…Scivita Medical Technology Co., Ltd.20251—
+5K241532Flexible Video-Choledo-Cysto-Ureteroscope System (PL-2100)Shanghai SeeGen Photoelectric Technology Co., Ltd.20240—
+5K240074Single use flexible ureteroscope (UR-D1); Single use flexible ureteroscope (UR-D2)…Shenzhen Besdata Technology Co., Ltd.20240—
+5K242108Ambu® aScope™ 5 Uretero (Standard Deflection); Ambu® aScope™ 5 Uretero (Reverse…Ambu A/S20240—
+5K233778Single Use Suction Access Ureteroscope (PU400A, PU411A), Single Use Flexible Video…Zhuhai Pusen Medical Technology Co., Ltd.20241—
+5K241598LithoVue Elite Single-Use Digital Flexible Ureteroscope - Standard (with pressure…Boston Scientific Corporation20241—
+5K233752Dragonfly™ Pancreaticobiliary Scope; Dragonfly™ Digital Controller; Dragonfly™…CenterPoint Systems, LLC20240—
+5K233472CVAC Aspiration System + CVAC Image ProcessorCalyxo, Inc.20243Class I
+5K231135Video Ureteroscope SystemHunan Vathin Medical Instrument Co., Ltd.20241—
+5K231774CoralView® Single-use Digital Flexible Ureteroscope (U10); CoralView® Single-use Digital…MacroLux Medical Technology Co., Ltd.20240—
+5K233645StoneSmart Connect Console, LithoVue Elite Standard Deflection, LithoVue Elite Reverse…Boston Scientific Corporation -202331
+5K230475Medical Video Endoscope SystemHuger Medical Instrument Co., Ltd.20232—
+5K223741Pusen Single Use Flexible Video Cystoscope/Choledochoscope System (Single Use Flexible…Zhuhai Pusen Medical Technology Co., Ltd.20230—
+5K230200Single-Use Flexible UreteroscopeHunan Vathin Medical Instrument Co., Ltd.20232—
+5K221158Single-Use Video Flexible Ureterorenoscope SystemGuangzhou Red Pine Medical Instrument Co., Ltd.20233—
+5K223466Uretero1 Single-Use Digital Flexible Ureteroscope (standard deflection), PN UROSD101…STERIS Corporation20232—
+5K212458Flexible Video-Uretero-Renoscope SSU SystemKarl Storz Endoscopy America20220—
+5K201897Sensor-Ureterorenoscope 9 FR WL 600 MM (short RIWO D-URS), Adapter For Controller 5525Richard Wolf Medical Instruments Corporation20210—
+5K201293Ureterorenoscope SystemShanghai AnQing Medical Instrument Co., Ltd.20204—
+5K193007LiNA OperaScope with HDMI cable and on-board LCD - 6 units, LiNA OperaScope Recording…Lina Medical Aps20200—
+5K181545Hysteroscope SystemShanghai AnQing Medical Instrument Co., Ltd.20192—
+5K183636SpyScope DS Access and Delivery Catheter, SpyScope DS II Access and Delivery Catheter…Boston Scientific Corporation20195—
+5K181977WiScope Digital Endoscope SystemOTU Medical, Inc.20183—
+5K170660Endosee Hysteroscope with Disposable Diagnostic (Dx) CannulaCooperSurgical, Inc.20175—
+5K132384U-Scope 8000 System with HSC+Emb CannulaEndosec Corporation201419—
+6K261447CVAC® Aspiration SystemCalyxo, Inc.20260—
+6K261153LithoVue Elite Digital Flexible Ureteroscope SystemBoston Scientific Corporation20260—
+6K262552Single-use Flexible Ureteroscope (Single-use Flexible Ureteroscope: SUV-5C-B)Scivita Medical Technology Co., Ltd.20260—
+6K260965CVAC Aspiration SystemCalyxo, Inc.20260—
+6K252929Single Use Digital Flexible Ureteroscope (7.5F); Videoscope Imaging Processor (Model…Anhui Happiness Workshop Instruments Co., Ltd.20260—
+6K260013CVAC Image ProcessorCalyxo, Inc.20260—
+6K251338Cholangioscope Visualization System (Single-use Video Cholangioscope: SCV-P-01G…Scivita Medical Technology Co., Ltd.20260—
+6K251951Single-Use Video Flexible Ureterorenoscope (RP-U-C03R9, RP-U-C03R3, RP-U-C03S9…Guangzhou Red Pine Medical Instrument Co., Ltd.20251—
+6K250917Flexible Ureterorenoscope system (Electronic Endoscope Image Processor, model…Shenzhen Sanping Image Technology Co., Ltd.20250—
+6K252703LithoVue Elite Single-Use Digital Flexible Ureteroscope - Standard with pressure…Boston Scientific Corporation20250—
+6K243155Single-Use Digital Flexible Ureteroscope (F-URS) (ZSR-URS-01, ZSR-URS-02, ZSR-URS-03…Dongguan Zsr Biomedical Technology Company Limited20250—
+6K243117Digital Video ProcessorHunan Vathin Medical Instrument Co., Ltd.20250—
+6K241956Single-Use Digital Flexible Ureteroscope (PUR12-1, PUR12-2, PUR12-3, PUR12-4, PUR12-5…Hunan Endoso Life Technology Co., Ltd.20250—
+6K240203URUS System (DMG-SU100/URUS); URUS System (DMG-SU100R/URUS); URUS System (VP-100/Video…Dyne Medical Group, Inc.20240—
+6K241639Single-use Video Ureterorenoscope (SVU-220US)Huger Medical Instrument Co., Ltd.20240—
+6K240374Ureterorenoscope SystemShenzhen HugeMed Medical Technical Development Co., Ltd.20240—
+6K231878Uretero1 Single-Use Digital Flexible Ureteroscope (standard deflection), PN UROSD101…STERIS Corporation20231—
+6K220159Flexible Ureterorenoscope (Model: US31D-12-EU), Flexible Ureterorenoscope (Model…Shanghai AnQing Medical Instrument Co., Ltd.20223—
+6K202445Hystero-V HysteroscopeHysterovue, Inc.20214—
+6K210270Medical Endoscope Image Processing SystemJiangsu Jiyuan Medical Technology Co., Ltd.20211—
+6K190797Reedgyn disposable hysteroscope (Model RH-2S-01 and Model RH-2D-01)Reed Medical (Zhejiang) Co., Ltd.20190—
+6K183020Endosee SystemCooperSurgical, Inc.201941
+6K151275MAKO DeviceNvision Medical20152—
+7K262488Single-Use Video Flexible Ureterorenoscope (RP-U-C06R9, RP-U-C06R3, RP-U-C06S9…Guangzhou Red Pine Medical Instrument Co., Ltd.20260—
+7K252793ARMI® Endoscopic Video Image Processor (JY-MIP-3000); ARMI® Single-Use Hysteroscope…Jiangsu Jiyuan Medical Technology Co., Ltd.20250—
+7K242699Flexible Ureteroscope (U-Scope)(2.8/1.2) (OMI161-2F28-CH12-US); Flexible Ureteroscope…Opcom Medical, Inc.20250—
+7K243857Flexible Ureterorenoscope (US27F-12-EU; US27F-12-US)Shanghai AnQing Medical Instrument Co., Ltd.20251—
+7K232003Endoscopic Video Image Processor, Single-Use Video HysteroscopeGuangzhou Red Pine Medical Instrument Co., Ltd.20243—
+7K222737Flexible Ureterorenoscope (Model: US31E-12-EU, US31E-12-US)Shanghai AnQing Medical Instrument Co., Ltd.20220—
+7K190639Endosee SystemCooperSurgical, Inc.201931
+7K160510MAKO 7Nvision Medical Corporation20161—
+8K252806Flexible Suction Ureterorenoscope (US27G-12-EU, US27G-12-US, US33G-17-EU, US33G-17-US…Shanghai AnQing Medical Instrument Co., Ltd.20250—
+8K240978SeleneView® Single-Use Digital Hysteroscope (HC29, HC29-G, HC35, HC35-G, HO35, HO35-G…MacroLux Medical Technology Co., Ltd.20241—
+8K241987Single-Use Video Hysteroscope (RP-G-C24, RP-G-C0101)Guangzhou Red Pine Medical Instrument Co., Ltd.20240—
+8K200038Endosee SystemCooperSurgical, Inc.20201—
+8K182975MAKO 7Boston Scientific Corporation20190—