510(k) Report

Devices descending from K904797

116 later devices reach Surgitek Graduated Cystoscope (Model GC-16) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K043022Stryker Flexible CystonephroscopeStryker Endoscopy200511—
+1K030960Ecn Electronic Video CystonephroscopeAcmi Corporation2003103—
+2K132389Cellvizio 100 Series System and Cellvizio System with Confocal Miniprobes; Uroflex B and…Daniel & Daniel Consulting201410—
+2K042069Invisio Irl Digital Rigid Laparoscope SystemAcmi Corporation20040—
+2K042225Acmi Invisio Icn, Models Icn-0564 and Icn-0565Acmi Corporation2004101—
+3K150831Cellvizio 100 Series System with Confocal MiniprobesMauna Kea Technologies20157—
+3K141358Cellvizio 100 Series with System Confocal MiniprobesMauna Kea Technologies20149—
+3K090814Modification to Gyrus Acmi Invisio Icn, Models Icn-0564 and Icn-0565Gyrus Acmi, Inc.20090—
+3K060269Acmi Dur-Digital Ureteroscope and Choledochoscope SystemAcmi Corporation200699—
+4K210579WiScope OM Endoscope System, WiScope Single-Use Digital Flexible…OTU Medical, Inc.20211—
+4K183640Cellvizio 100 Series Confocal laser Imaging systems and their Confocal MiniprobesMauna Kea Technologies20194—
+4K172844Cellvizio 100 Series System with Confocal MiniprobesMauna Kea Technologies20176—
+4K160416CystoFlex UHD R-C, CelioFlex UHD 5-C, Cellvizio 100 Series (800) with Confocal MiniprobesMauna Kea Technologies20167—
+4K153049LithoVue SystemBoston Scientific Corporation201524—
+4K142922SpyGlass DS Direct Visualization SystemBoston Scientific Corporation201591
+4K142556Flexible Video-Uretero-Choledochoscope SystemKARL STORZ Endoscopy-America, Inc.20147—
+4K131369Flexible Video-Uretero-Renoscope SystemKARL STORZ Endoscopy-America, Inc.2013531
+4K092278Gyrus Acmi Invisio Digital Hysteroscope, Model Idh-4Gyrus Acmi, Inc.200922—
+4K072594Gyrus Acmi Ipn-2505, Invisio Smith Percutaneous Nephroscope SystemGyrus Acmi, Inc.200723—
+5K254153Single-use Video Scope; PB Digital ControllerMirco-Tech (Nanjing) Co., Ltd.20260—
+5K241444Biliary Pancreaticobiliary Scope SystemShenzhen HugeMed Medical Technical Development Co., Ltd.20250—
+5K241275Histolog® Scanner (Hardware 2.4, Software 3.3)Samantree Medical SA20240—
+5K233630Ambu® aScope™ 5 Uretero (Standard Deflection); Ambu® aScope™ 5 Uretero (Reverse…Ambu A/S20241—
+5K233275RenaFlex Single-use Flexible Ureteroscope (SUURF-V Standard); RenaFlex Single-use…Gyrus Acmi, Inc.20240—
+5K231497Choledochoscope SystemShenzhen HugeMed Medical Technical Development Co., Ltd.20240—
+5K223097RenaNav Ureteroscope SystemCenterPoint Systems, LLC20230—
+5K221784Single-use Video Pancreaticobiliary Scope, PB Digital ControllerMicro-Tech (Nanjing) Co., Ltd.20232—
+5K221515StoneSmart Connect Console, LithoVue Elite Single Use Digital Flexible Ureteroscope…Boston Scientific Corporation20234—
+5K213334Monarch Platform, UrologyAuris Health, Inc.202201
+5K211686Flexible Video-Choledo-Cysto-Ureteroscope SystemShanghai SeeGen Photoelectric Technology Co., Ltd.20222—
+5K211347Uretero1 Ureteroscope SystemSTERIS Corporation20213—
+5K200483SpyGlass Discover Digital Catheter, SpyGlass Discover Digital ControllerBoston Scientific Corporation20203—
+5K193416Cellvizio I.V.E. with Confocal MiniprobesMauna Kea Technologies20200—
+5K191144Cellvizio 100 Series System with Confocal MiniprobesMauna Kea Technologies20202—
+5K183188Flexible Sensor-Ureterorenoscopes BOA Vision EF, Flexible Sensor-Ureterorenoscopes COBRA…Richard Wolf Medical Instruments Corporation20191—
+5K181439SpyGlass DS and DS II Direct Visualization SystemBoston Scientific Corporation20187—
+5K180367Ureterorenoscope SystemShanghai AnQing Medical Instrument Co., Ltd.20189—
+5K171113LiNA OperaScope with HDMI cable and on-board LCD-single unit, LiNA OperaScope with HDMI…Lina Medical Aps20184—
+5K172098Medical Video Endoscope SystemZhuhai Pusen Medical Technology Co., Ltd.201723—
+5K171076Medical Video Endoscope SystemZhuhai Pusen Medical Technology Co., Ltd.20174—
+5K141250Flexible Video-Uretero-Renoscope SystemKARL STORZ Endoscopy-America, Inc.2014112
+5K123151Endosee Model 8000 U-ScopeEndosee Corp201320—
+5K093218Femeye TwoFem Suite, LLC20100—
+6K260516BubbleView Single-Use Digital Flexible Cystoscope (C38-CS, C38-CRS, C50-C, C50-CR…MacroLux Medical Technology Co., Ltd.20260—
+6K252492Visualized Access and Delivery Catheter; PB Digital ControllerMicro-Tech (Nanjing) Co., Ltd.20260—
+6K252468Single-use Digital Flexible Ureteroscope (GY-UR9.3); Single-use Digital Flexible…Zhejiang Geyi Medical Instrument Co., Ltd.20250—
+6K250049Medical Video Endoscope [Standard Deflection] (URS3005); Medical Video Endoscope…Seplou (Zhuhai) Co., Ltd.20250—
+6K243711Confocal Microprobe Imaging System (BrightP980); Confocal Microprobe Imaging System…Wuxi Hisky Medical Technologies Co., Ltd.20250—
+6K243550KARL STORZ Flexible Video-Uretero-Renoscope (FLEX XC)Karl Storz SE & CO. KG20250—
+6K250785Single-use Flexible UreteroscopeHunan Vathin Medical Instrument Co., Ltd.20250—
+6K243894F88 URE-SD/RD Flexible UreteroscopeSg Endoscopy Pte, Ltd.20250—
+6K243532LumiRex UreteroscopeContra Healthcare Solutions, LLC20250—
+6K243708Urology Videoscope System (Single-use Flexible Ureteroscope: SUV-1A-B, SUV-1A-P…Scivita Medical Technology Co., Ltd.20251—
+6K241532Flexible Video-Choledo-Cysto-Ureteroscope System (PL-2100)Shanghai SeeGen Photoelectric Technology Co., Ltd.20240—
+6K240074Single use flexible ureteroscope (UR-D1); Single use flexible ureteroscope (UR-D2)…Shenzhen Besdata Technology Co., Ltd.20240—
+6K242108Ambu® aScope™ 5 Uretero (Standard Deflection); Ambu® aScope™ 5 Uretero (Reverse…Ambu A/S20240—
+6K233778Single Use Suction Access Ureteroscope (PU400A, PU411A), Single Use Flexible Video…Zhuhai Pusen Medical Technology Co., Ltd.20241—
+6K241598LithoVue Elite Single-Use Digital Flexible Ureteroscope - Standard (with pressure…Boston Scientific Corporation20241—
+6K233752Dragonfly™ Pancreaticobiliary Scope; Dragonfly™ Digital Controller; Dragonfly™…CenterPoint Systems, LLC20240—
+6K233472CVAC Aspiration System + CVAC Image ProcessorCalyxo, Inc.20243Class I
+6K231135Video Ureteroscope SystemHunan Vathin Medical Instrument Co., Ltd.20241—
+6K231774CoralView® Single-use Digital Flexible Ureteroscope (U10); CoralView® Single-use Digital…MacroLux Medical Technology Co., Ltd.20240—
+6K233645StoneSmart Connect Console, LithoVue Elite Standard Deflection, LithoVue Elite Reverse…Boston Scientific Corporation -202331
+6K230475Medical Video Endoscope SystemHuger Medical Instrument Co., Ltd.20232—
+6K223741Pusen Single Use Flexible Video Cystoscope/Choledochoscope System (Single Use Flexible…Zhuhai Pusen Medical Technology Co., Ltd.20230—
+6K230200Single-Use Flexible UreteroscopeHunan Vathin Medical Instrument Co., Ltd.20232—
+6K221158Single-Use Video Flexible Ureterorenoscope SystemGuangzhou Red Pine Medical Instrument Co., Ltd.20233—
+6K223466Uretero1 Single-Use Digital Flexible Ureteroscope (standard deflection), PN UROSD101…STERIS Corporation20232—
+6K212458Flexible Video-Uretero-Renoscope SSU SystemKarl Storz Endoscopy America20220—
+6K212322Cellvizio I.V.E. system with Confocal MiniprobesMauna Kea Technologies20210—
+6K201897Sensor-Ureterorenoscope 9 FR WL 600 MM (short RIWO D-URS), Adapter For Controller 5525Richard Wolf Medical Instruments Corporation20210—
+6K201293Ureterorenoscope SystemShanghai AnQing Medical Instrument Co., Ltd.20204—
+6K193007LiNA OperaScope with HDMI cable and on-board LCD - 6 units, LiNA OperaScope Recording…Lina Medical Aps20200—
+6K181545Hysteroscope SystemShanghai AnQing Medical Instrument Co., Ltd.20192—
+6K183636SpyScope DS Access and Delivery Catheter, SpyScope DS II Access and Delivery Catheter…Boston Scientific Corporation20195—
+6K181977WiScope Digital Endoscope SystemOTU Medical, Inc.20183—
+6K170660Endosee Hysteroscope with Disposable Diagnostic (Dx) CannulaCooperSurgical, Inc.20175—
+6K132384U-Scope 8000 System with HSC+Emb CannulaEndosec Corporation201419—
+7K261447CVAC® Aspiration SystemCalyxo, Inc.20260—
+7K261153LithoVue Elite Digital Flexible Ureteroscope SystemBoston Scientific Corporation20260—
+7K262552Single-use Flexible Ureteroscope (Single-use Flexible Ureteroscope: SUV-5C-B)Scivita Medical Technology Co., Ltd.20260—
+7K260965CVAC Aspiration SystemCalyxo, Inc.20260—
+7K252929Single Use Digital Flexible Ureteroscope (7.5F); Videoscope Imaging Processor (Model…Anhui Happiness Workshop Instruments Co., Ltd.20260—
+7K260013CVAC Image ProcessorCalyxo, Inc.20260—
+7K251338Cholangioscope Visualization System (Single-use Video Cholangioscope: SCV-P-01G…Scivita Medical Technology Co., Ltd.20260—
+7K251951Single-Use Video Flexible Ureterorenoscope (RP-U-C03R9, RP-U-C03R3, RP-U-C03S9…Guangzhou Red Pine Medical Instrument Co., Ltd.20251—
+7K250917Flexible Ureterorenoscope system (Electronic Endoscope Image Processor, model…Shenzhen Sanping Image Technology Co., Ltd.20250—
+7K252703LithoVue Elite Single-Use Digital Flexible Ureteroscope - Standard with pressure…Boston Scientific Corporation20250—
+7K243155Single-Use Digital Flexible Ureteroscope (F-URS) (ZSR-URS-01, ZSR-URS-02, ZSR-URS-03…Dongguan Zsr Biomedical Technology Company Limited20250—
+7K243117Digital Video ProcessorHunan Vathin Medical Instrument Co., Ltd.20250—
+7K241956Single-Use Digital Flexible Ureteroscope (PUR12-1, PUR12-2, PUR12-3, PUR12-4, PUR12-5…Hunan Endoso Life Technology Co., Ltd.20250—
+7K240203URUS System (DMG-SU100/URUS); URUS System (DMG-SU100R/URUS); URUS System (VP-100/Video…Dyne Medical Group, Inc.20240—
+7K241639Single-use Video Ureterorenoscope (SVU-220US)Huger Medical Instrument Co., Ltd.20240—
+7K240374Ureterorenoscope SystemShenzhen HugeMed Medical Technical Development Co., Ltd.20240—
+7K231878Uretero1 Single-Use Digital Flexible Ureteroscope (standard deflection), PN UROSD101…STERIS Corporation20231—
+7K220159Flexible Ureterorenoscope (Model: US31D-12-EU), Flexible Ureterorenoscope (Model…Shanghai AnQing Medical Instrument Co., Ltd.20223—
+7K202445Hystero-V HysteroscopeHysterovue, Inc.20214—
+7K210270Medical Endoscope Image Processing SystemJiangsu Jiyuan Medical Technology Co., Ltd.20211—
+7K190797Reedgyn disposable hysteroscope (Model RH-2S-01 and Model RH-2D-01)Reed Medical (Zhejiang) Co., Ltd.20190—
+7K183020Endosee SystemCooperSurgical, Inc.201941