510(k) Report

Devices descending from K993041

271 later devices reach Olympus Xcyf-1T3 Oes Cystofiberscope/Nephrofiberscope Accessories and… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K233752Dragonfly™ Pancreaticobiliary Scope; Dragonfly™ Digital Controller; Dragonfly™…CenterPoint Systems, LLC20240—
+7K233472CVAC Aspiration System + CVAC Image ProcessorCalyxo, Inc.20243Class I
+7K231135Video Ureteroscope SystemHunan Vathin Medical Instrument Co., Ltd.20241—
+7K231774CoralView® Single-use Digital Flexible Ureteroscope (U10); CoralView® Single-use Digital…MacroLux Medical Technology Co., Ltd.20240—
+7K233645StoneSmart Connect Console, LithoVue Elite Standard Deflection, LithoVue Elite Reverse…Boston Scientific Corporation -202331
+7K230475Medical Video Endoscope SystemHuger Medical Instrument Co., Ltd.20232—
+7K223741Pusen Single Use Flexible Video Cystoscope/Choledochoscope System (Single Use Flexible…Zhuhai Pusen Medical Technology Co., Ltd.20230—
+7K230200Single-Use Flexible UreteroscopeHunan Vathin Medical Instrument Co., Ltd.20232—
+7K221158Single-Use Video Flexible Ureterorenoscope SystemGuangzhou Red Pine Medical Instrument Co., Ltd.20233—
+7K223759Arthrex SynergyID Endoscopic Imaging SystemArthex, Inc.20234—
+7K223466Uretero1 Single-Use Digital Flexible Ureteroscope (standard deflection), PN UROSD101…STERIS Corporation20232—
+7K212458Flexible Video-Uretero-Renoscope SSU SystemKarl Storz Endoscopy America20220—
+7K203717Processor VP-7000, Light Source BL-7000X, Image Processing Unit EX-0Fujifilm Corporaton20213—
+7K201897Sensor-Ureterorenoscope 9 FR WL 600 MM (short RIWO D-URS), Adapter For Controller 5525Richard Wolf Medical Instruments Corporation20210—
+7K202469G-EYE SystemSmart Medical Systems, Ltd.20201—
+7K202130FUJIFILM Video LaparoscopeFujifilm Corporation20201—
+7K201293Ureterorenoscope SystemShanghai AnQing Medical Instrument Co., Ltd.20204—
+7K193007LiNA OperaScope with HDMI cable and on-board LCD - 6 units, LiNA OperaScope Recording…Lina Medical Aps20200—
+7K181545Hysteroscope SystemShanghai AnQing Medical Instrument Co., Ltd.20192—
+7K183636SpyScope DS Access and Delivery Catheter, SpyScope DS II Access and Delivery Catheter…Boston Scientific Corporation20195—
+7K181977WiScope Digital Endoscope SystemOTU Medical, Inc.20183—
+7K170660Endosee Hysteroscope with Disposable Diagnostic (Dx) CannulaCooperSurgical, Inc.20175—
+7K132384U-Scope 8000 System with HSC+Emb CannulaEndosec Corporation201419—
+8K261447CVAC® Aspiration SystemCalyxo, Inc.20260—
+8K261153LithoVue Elite Digital Flexible Ureteroscope SystemBoston Scientific Corporation20260—
+8K262552Single-use Flexible Ureteroscope (Single-use Flexible Ureteroscope: SUV-5C-B)Scivita Medical Technology Co., Ltd.20260—
+8K260573EvoEndo Single-Use Endoscopy SystemEvoEndo, Inc.20260—
+8K260965CVAC Aspiration SystemCalyxo, Inc.20260—
+8K252929Single Use Digital Flexible Ureteroscope (7.5F); Videoscope Imaging Processor (Model…Anhui Happiness Workshop Instruments Co., Ltd.20260—
+8K260013CVAC Image ProcessorCalyxo, Inc.20260—
+8K251338Cholangioscope Visualization System (Single-use Video Cholangioscope: SCV-P-01G…Scivita Medical Technology Co., Ltd.20260—
+8K251951Single-Use Video Flexible Ureterorenoscope (RP-U-C03R9, RP-U-C03R3, RP-U-C03S9…Guangzhou Red Pine Medical Instrument Co., Ltd.20251—
+8K250917Flexible Ureterorenoscope system (Electronic Endoscope Image Processor, model…Shenzhen Sanping Image Technology Co., Ltd.20250—
+8K252703LithoVue Elite Single-Use Digital Flexible Ureteroscope - Standard with pressure…Boston Scientific Corporation20250—
+8K250268HyperSnap Surgical System (HSS)Hypervision Surgical20251—
+8K243155Single-Use Digital Flexible Ureteroscope (F-URS) (ZSR-URS-01, ZSR-URS-02, ZSR-URS-03…Dongguan Zsr Biomedical Technology Company Limited20250—
+8K243117Digital Video ProcessorHunan Vathin Medical Instrument Co., Ltd.20250—
+8K241956Single-Use Digital Flexible Ureteroscope (PUR12-1, PUR12-2, PUR12-3, PUR12-4, PUR12-5…Hunan Endoso Life Technology Co., Ltd.20250—
+8K240203URUS System (DMG-SU100/URUS); URUS System (DMG-SU100R/URUS); URUS System (VP-100/Video…Dyne Medical Group, Inc.20240—
+8K241639Single-use Video Ureterorenoscope (SVU-220US)Huger Medical Instrument Co., Ltd.20240—
+8K233225SCHOELLY Oxygen Saturation Imaging (OSI) Camera System (Camera Control Unit, Camera Head…Schoelly Fiberoptic GmbH20240—
+8K240374Ureterorenoscope SystemShenzhen HugeMed Medical Technical Development Co., Ltd.20240—
+8K233451Arthrex Synergy Vision Endoscopic Imaging SystemArthrex, Inc.20243—
+8K231878Uretero1 Single-Use Digital Flexible Ureteroscope (standard deflection), PN UROSD101…STERIS Corporation20231—
+8K220159Flexible Ureterorenoscope (Model: US31D-12-EU), Flexible Ureterorenoscope (Model…Shanghai AnQing Medical Instrument Co., Ltd.20223—
+8K220158G-EYE SystemSmart Medical Systems, Ltd.20220—
+8K212950FUJIFILM Video Laparoscope EL-R740M30Fujifilm Corporaton20210—
+8K202445Hystero-V HysteroscopeHysterovue, Inc.20214—
+8K210270Medical Endoscope Image Processing SystemJiangsu Jiyuan Medical Technology Co., Ltd.20211—
+8K190797Reedgyn disposable hysteroscope (Model RH-2S-01 and Model RH-2D-01)Reed Medical (Zhejiang) Co., Ltd.20190—
+8K183020Endosee SystemCooperSurgical, Inc.201941
+8K151275MAKO DeviceNvision Medical20152—
+9K262488Single-Use Video Flexible Ureterorenoscope (RP-U-C06R9, RP-U-C06R3, RP-U-C06S9…Guangzhou Red Pine Medical Instrument Co., Ltd.20260—
+9K253984Instrument Exit Point on Touch Surgery™ AideCovidien, LLC20260—
+9K252793ARMI® Endoscopic Video Image Processor (JY-MIP-3000); ARMI® Single-Use Hysteroscope…Jiangsu Jiyuan Medical Technology Co., Ltd.20250—
+9K242699Flexible Ureteroscope (U-Scope)(2.8/1.2) (OMI161-2F28-CH12-US); Flexible Ureteroscope…Opcom Medical, Inc.20250—
+9K243857Flexible Ureterorenoscope (US27F-12-EU; US27F-12-US)Shanghai AnQing Medical Instrument Co., Ltd.20251—
+9K241361Arthrex Synergy Vision Endoscopic Imaging SystemArthrex, Inc.20242—
+9K232003Endoscopic Video Image Processor, Single-Use Video HysteroscopeGuangzhou Red Pine Medical Instrument Co., Ltd.20243—
+9K222737Flexible Ureterorenoscope (Model: US31E-12-EU, US31E-12-US)Shanghai AnQing Medical Instrument Co., Ltd.20220—
+9K190639Endosee SystemCooperSurgical, Inc.201931
+9K160510MAKO 7Nvision Medical Corporation20161—
+10K252806Flexible Suction Ureterorenoscope (US27G-12-EU, US27G-12-US, US33G-17-EU, US33G-17-US…Shanghai AnQing Medical Instrument Co., Ltd.20250—
+10K250728Arthrex Synergy Vision Endoscopic Imaging SystemArthrex, Inc.20251—
+10K240978SeleneView® Single-Use Digital Hysteroscope (HC29, HC29-G, HC35, HC35-G, HO35, HO35-G…MacroLux Medical Technology Co., Ltd.20241—
+10K241987Single-Use Video Hysteroscope (RP-G-C24, RP-G-C0101)Guangzhou Red Pine Medical Instrument Co., Ltd.20240—
+10K200038Endosee SystemCooperSurgical, Inc.20201—
+10K182975MAKO 7Boston Scientific Corporation20190—
+11K254294Single-use Digital Hysteroscope (GYUT-A 12.6- 0, GYUT-A12.6- 12, GYUT-A 12.6- 22, GYUT-A…Zhejiang Geyi Medical Instrument Co., Ltd.20260—
+11K254251InnovexView (GC146-17, GC150-20, GC155-23)Shanghai AnQing Medical Instrument Co., Ltd.20260—
+11K251994Arthrex Synergy Vision Imaging SystemArthrex, Inc.20250—