510(k) Report

Devices descending from K944072

434 later devices reach Olympus Nasal and Sinus Endoscopes through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K093218Femeye TwoFem Suite, LLC20100—
+8K260309Ambu® aScope™ 5 Broncho 2.7/1.2; Ambu® aScope™ 5 Broncho 4.2/2.2; Ambu® aScope™ 5…Ambu A/S20260—
+8K260516BubbleView Single-Use Digital Flexible Cystoscope (C38-CS, C38-CRS, C50-C, C50-CR…MacroLux Medical Technology Co., Ltd.20260—
+8K261880FUJIFILM Processor EP-8000;Balloon Controller PB-30;Endoscopy Support Program EW10-VM01Fujifilm Corporation20260—
+8K252492Visualized Access and Delivery Catheter; PB Digital ControllerMicro-Tech (Nanjing) Co., Ltd.20260—
+8K252468Single-use Digital Flexible Ureteroscope (GY-UR9.3); Single-use Digital Flexible…Zhejiang Geyi Medical Instrument Co., Ltd.20250—
+8K251708EvoEndo Single-Use Endoscopy SystemEvoEndo, Inc.20251—
+8K250049Medical Video Endoscope [Standard Deflection] (URS3005); Medical Video Endoscope…Seplou (Zhuhai) Co., Ltd.20250—
+8K250900EvoEndo Single-Use Endoscopy SystemEvoEndo, Inc.20250—
+8K243550KARL STORZ Flexible Video-Uretero-Renoscope (FLEX XC)Karl Storz SE & CO. KG20250—
+8K250785Single-use Flexible UreteroscopeHunan Vathin Medical Instrument Co., Ltd.20250—
+8K243894F88 URE-SD/RD Flexible UreteroscopeSg Endoscopy Pte, Ltd.20250—
+8K243532LumiRex UreteroscopeContra Healthcare Solutions, LLC20250—
+8K243708Urology Videoscope System (Single-use Flexible Ureteroscope: SUV-1A-B, SUV-1A-P…Scivita Medical Technology Co., Ltd.20251—
+8K243380Visera S Video System Center Olympus Otv-S500 (Olympus Otv-S500)Olympus Medical Systems Corporation20250—
+8K241532Flexible Video-Choledo-Cysto-Ureteroscope System (PL-2100)Shanghai SeeGen Photoelectric Technology Co., Ltd.20240—
+8K240074Single use flexible ureteroscope (UR-D1); Single use flexible ureteroscope (UR-D2)…Shenzhen Besdata Technology Co., Ltd.20240—
+8K233827OxiWearOxiwear, Inc.20240—
+8K233942PENTAX Medical Video Duodenoscope (ED34-i10T2s); PENTAX Medical Video Processor…Pentax of America, Inc.20240—
+8K233778Single Use Suction Access Ureteroscope (PU400A, PU411A), Single Use Flexible Video…Zhuhai Pusen Medical Technology Co., Ltd.20241—
+8K241598LithoVue Elite Single-Use Digital Flexible Ureteroscope - Standard (with pressure…Boston Scientific Corporation20241—
+8K233752Dragonfly™ Pancreaticobiliary Scope; Dragonfly™ Digital Controller; Dragonfly™…CenterPoint Systems, LLC20240—
+8K233472CVAC Aspiration System + CVAC Image ProcessorCalyxo, Inc.20243Class I
+8K231135Video Ureteroscope SystemHunan Vathin Medical Instrument Co., Ltd.20241—
+8K231774CoralView® Single-use Digital Flexible Ureteroscope (U10); CoralView® Single-use Digital…MacroLux Medical Technology Co., Ltd.20240—
+8K233645StoneSmart Connect Console, LithoVue Elite Standard Deflection, LithoVue Elite Reverse…Boston Scientific Corporation -202331
+8K230475Medical Video Endoscope SystemHuger Medical Instrument Co., Ltd.20232—
+8K223741Pusen Single Use Flexible Video Cystoscope/Choledochoscope System (Single Use Flexible…Zhuhai Pusen Medical Technology Co., Ltd.20230—
+8K230200Single-Use Flexible UreteroscopeHunan Vathin Medical Instrument Co., Ltd.20232—
+8K221158Single-Use Video Flexible Ureterorenoscope SystemGuangzhou Red Pine Medical Instrument Co., Ltd.20233—
+8K223759Arthrex SynergyID Endoscopic Imaging SystemArthex, Inc.20234—
+8K223466Uretero1 Single-Use Digital Flexible Ureteroscope (standard deflection), PN UROSD101…STERIS Corporation20232—
+8K223127HemoSphere Advanced Monitoring Platform, HemoSphere ForeSight Oximeter cableEdwards Lifeciences, LLC20226—
+8K212458Flexible Video-Uretero-Renoscope SSU SystemKarl Storz Endoscopy America20220—
+8K203717Processor VP-7000, Light Source BL-7000X, Image Processing Unit EX-0Fujifilm Corporaton20213—
+8K203490FORE-SIGHT ELITE Absolute Tissue OximeterEdwards Lifesciences, LLC202101
+8K201897Sensor-Ureterorenoscope 9 FR WL 600 MM (short RIWO D-URS), Adapter For Controller 5525Richard Wolf Medical Instruments Corporation20210—
+8K202469G-EYE SystemSmart Medical Systems, Ltd.20201—
+8K202130FUJIFILM Video LaparoscopeFujifilm Corporation20201—
+8K201293Ureterorenoscope SystemShanghai AnQing Medical Instrument Co., Ltd.20204—
+8K193007LiNA OperaScope with HDMI cable and on-board LCD - 6 units, LiNA OperaScope Recording…Lina Medical Aps20200—
+8K190205HemoSphere Advanced Monitor, HemoSphere Tissue Oximetry ModuleEdwards Lifesciences, LLC201934—
+8K182429Masimo O3 Regional Oximeter SystemMasimo Corporation20193—
+8K181545Hysteroscope SystemShanghai AnQing Medical Instrument Co., Ltd.20192—
+8K183636SpyScope DS Access and Delivery Catheter, SpyScope DS II Access and Delivery Catheter…Boston Scientific Corporation20195—
+8K181977WiScope Digital Endoscope SystemOTU Medical, Inc.20183—
+8K180003FORE-SIGHT ELITE Module Tissue OximeterCas Medical Systems, Inc.2018291
+8K170660Endosee Hysteroscope with Disposable Diagnostic (Dx) CannulaCooperSurgical, Inc.20175—
+8K162603Masimo O3 Regional Oximeter SystemMasimo Corporation20170—
+8K132384U-Scope 8000 System with HSC+Emb CannulaEndosec Corporation201419—
+9K261447CVAC® Aspiration SystemCalyxo, Inc.20260—
+9K261153LithoVue Elite Digital Flexible Ureteroscope SystemBoston Scientific Corporation20260—
+9K262552Single-use Flexible Ureteroscope (Single-use Flexible Ureteroscope: SUV-5C-B)Scivita Medical Technology Co., Ltd.20260—
+9K260573EvoEndo Single-Use Endoscopy SystemEvoEndo, Inc.20260—
+9K260965CVAC Aspiration SystemCalyxo, Inc.20260—
+9K252929Single Use Digital Flexible Ureteroscope (7.5F); Videoscope Imaging Processor (Model…Anhui Happiness Workshop Instruments Co., Ltd.20260—
+9K260013CVAC Image ProcessorCalyxo, Inc.20260—
+9K251338Cholangioscope Visualization System (Single-use Video Cholangioscope: SCV-P-01G…Scivita Medical Technology Co., Ltd.20260—
+9K251951Single-Use Video Flexible Ureterorenoscope (RP-U-C03R9, RP-U-C03R3, RP-U-C03S9…Guangzhou Red Pine Medical Instrument Co., Ltd.20251—
+9K250917Flexible Ureterorenoscope system (Electronic Endoscope Image Processor, model…Shenzhen Sanping Image Technology Co., Ltd.20250—
+9K252703LithoVue Elite Single-Use Digital Flexible Ureteroscope - Standard with pressure…Boston Scientific Corporation20250—
+9K250268HyperSnap Surgical System (HSS)Hypervision Surgical20251—
+9K243155Single-Use Digital Flexible Ureteroscope (F-URS) (ZSR-URS-01, ZSR-URS-02, ZSR-URS-03…Dongguan Zsr Biomedical Technology Company Limited20250—
+9K243117Digital Video ProcessorHunan Vathin Medical Instrument Co., Ltd.20250—
+9K241956Single-Use Digital Flexible Ureteroscope (PUR12-1, PUR12-2, PUR12-3, PUR12-4, PUR12-5…Hunan Endoso Life Technology Co., Ltd.20250—
+9K240203URUS System (DMG-SU100/URUS); URUS System (DMG-SU100R/URUS); URUS System (VP-100/Video…Dyne Medical Group, Inc.20240—
+9K241639Single-use Video Ureterorenoscope (SVU-220US)Huger Medical Instrument Co., Ltd.20240—
+9K233225SCHOELLY Oxygen Saturation Imaging (OSI) Camera System (Camera Control Unit, Camera Head…Schoelly Fiberoptic GmbH20240—
+9K240374Ureterorenoscope SystemShenzhen HugeMed Medical Technical Development Co., Ltd.20240—
+9K233451Arthrex Synergy Vision Endoscopic Imaging SystemArthrex, Inc.20243—
+9K230612Edwards Algorithm for Measurement of Blood HemoglobinEdwards Lifesciences, LLC20235—
+9K231878Uretero1 Single-Use Digital Flexible Ureteroscope (standard deflection), PN UROSD101…STERIS Corporation20231—
+9K220159Flexible Ureterorenoscope (Model: US31D-12-EU), Flexible Ureterorenoscope (Model…Shanghai AnQing Medical Instrument Co., Ltd.20223—
+9K220158G-EYE SystemSmart Medical Systems, Ltd.20220—
+9K212950FUJIFILM Video Laparoscope EL-R740M30Fujifilm Corporaton20210—
+9K202445Hystero-V HysteroscopeHysterovue, Inc.20214—
+9K210270Medical Endoscope Image Processing SystemJiangsu Jiyuan Medical Technology Co., Ltd.20211—
+9K203131EV1000 Clinical Platform Non-Invasive (NI) or ClearSight System, EV1000 Clinical PlatformEdwards Lifesciences, LLC20210—
+9K200717CLEWICU System (ClewICUServer and ClewICUnitor)Clew Medical, Ltd.202112—
+9K201446HemoSphere Advanced Monitoring Platform, HemoSphere ClearSight ModuleEdwards Lifesiences, LLC2020271
+9K201432Masimo O3 Regional Oximeter SystemMasimo Corporation20202—
+9K190797Reedgyn disposable hysteroscope (Model RH-2S-01 and Model RH-2D-01)Reed Medical (Zhejiang) Co., Ltd.20190—
+9K190270FORE-SIGHT ELITE Tissue Oximeter ModuleCas Medical Systems, Inc.201915—
+9K183020Endosee SystemCooperSurgical, Inc.201941
+9K151275MAKO DeviceNvision Medical20152—
+10K262488Single-Use Video Flexible Ureterorenoscope (RP-U-C06R9, RP-U-C06R3, RP-U-C06S9…Guangzhou Red Pine Medical Instrument Co., Ltd.20260—
+10K253984Instrument Exit Point on Touch Surgery™ AideCovidien, LLC20260—
+10K252793ARMI® Endoscopic Video Image Processor (JY-MIP-3000); ARMI® Single-Use Hysteroscope…Jiangsu Jiyuan Medical Technology Co., Ltd.20250—
+10K242699Flexible Ureteroscope (U-Scope)(2.8/1.2) (OMI161-2F28-CH12-US); Flexible Ureteroscope…Opcom Medical, Inc.20250—
+10K243857Flexible Ureterorenoscope (US27F-12-EU; US27F-12-US)Shanghai AnQing Medical Instrument Co., Ltd.20251—
+10K242451HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta-…Edwards Lifesciences20244—
+10K241361Arthrex Synergy Vision Endoscopic Imaging SystemArthrex, Inc.20242—
+10K233253eCARTv5 Clinical Deterioration Suite (“eCART”)Agilemd, Inc.20241—
+10K232003Endoscopic Video Image Processor, Single-Use Video HysteroscopeGuangzhou Red Pine Medical Instrument Co., Ltd.20243—
+10K233216CLEWICU SystemClew Medical, Ltd.20240—
+10K231038Global Hypoperfusion Index (GHI) AlgorithmEdwards Lifesciences, LLC20236—
+10K221833HemoSphere Advanced Monitor, HemoSphere ClearSight ModuleEdwards Lifesciences, LLC20227—
+10K222737Flexible Ureterorenoscope (Model: US31E-12-EU, US31E-12-US)Shanghai AnQing Medical Instrument Co., Ltd.20220—
+10K213682HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable…Edwards Lifesciences, LLC202214—
+10K214072Masimo O3 Regional Oximeter SystemMasimo Corporation20221—