510(k) Report

Devices descending from K023984

350 later devices reach Modification to Olympus Bronchoscopes BF-40 Series, BF-240 Series, and BF-160… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K252598Flexible Cystoscope (CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US)Shanghai AnQing Medical Instrument Co., Ltd.20250—
+5K250939SIRIUS Endoscope System (PR-SI-1230)Precision Robotics (Hong Kong) Limited20250—
+5K244017FUJIFILM Endoscope Model EB-710P; FUJIFILM Processor EP-8000Fujifilm Corporation20250—
+5K251127PENTAX Medical Video Processor (EPK-i8020c)Pentax of America, Inc.202501
+5K243497Portable Video Processor (EA101), Flexible Bronchoscope BS41H-12EU, BS41H-12US…Shanghai AnQing Medical Instrument Co., Ltd.20251—
+5K243541LumiRex BronchoscopeContra Healthcare Solutions, LLC20250—
+5K243260FUJIFILM Processor EP-8000; FUJIFILM Endoscope Model EG-860RFujifilm Corporation20251—
+5K242010Bronchoscope System, The Single-use Bronchoscope (Single-use Bronchoscope: SP-Y-ZQGJ2.8…Shenzhen Sanping Image Technology Co., Ltd.20250—
+5K243380Visera S Video System Center Olympus Otv-S500 (Olympus Otv-S500)Olympus Medical Systems Corporation20250—
+5K241444Biliary Pancreaticobiliary Scope SystemShenzhen HugeMed Medical Technical Development Co., Ltd.20250—
+5K243502Evis Eus Endoscopic Ultrasound Center Olympus EU-ME3 (Olympus EU-ME3)Olympus Medical Systems Corporation20250—
+5K242108Ambu® aScope™ 5 Uretero (Standard Deflection); Ambu® aScope™ 5 Uretero (Reverse…Ambu A/S20240—
+5K241371Visera S Video System Center Olympus Otv-S500 (Olympus Otv-S500)Olympus Medical Systems Corporation20240—
+5K240283BubbleView™ Single-Use Digital Flexible Cystoscope (C50-C, C50-CR, C50-CB, C50-CBR)…MacroLux Medical Technology Co., Ltd.20240—
+5K231107Bronchoscope SystemHunan Endoso Life Technology Co., Ltd.20241—
+5K232860PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Bronchoscope EB11-J10…Pentax of America, Inc.20241—
+5K231970PENTAX Medical Single Use Video Bronchoscope EB11-S01, PENTAX Medical Single Use Video…Pentax of America, Inc.20240—
+5K232249PENTAX Medical Gas/Water Feeding Valve OE-B14Pentax of America, Inc.20230—
+5K232244Disposable Endoscope Valves SystemChangzhou Endoclean Medical Device Co., Ltd.20230—
+5K232028Q Vision Sterile Single Use Adult Flexible Gastroscope (G-100); Q Base Reusable Base…Iq Endoscopes Limited20230—
+5K231702WiScope® Digital Cystoscope System, WiScope® Single-Use Digital Flexible Cystoscope…OTU Medical, Inc.20230—
+5K222584Evis X1 Video System Center Olympus CV-1500, Colonovideoscope Olympus CF-HQ1100DL/I…Olympus Medical Systems Corporation202321
+5K221784Single-use Video Pancreaticobiliary Scope, PB Digital ControllerMicro-Tech (Nanjing) Co., Ltd.20232—
+5K222020HD-550 Video Endoscope SystemSonoscape Medical Corp.20220—
+5K222014EXALT Model B Single-Use BronchoscopeBoston Scientific Corporation20220—
+5K212886Broncoflex Agile, Broncoflex Vortex, ScreeniAxess Vision Technology20220—
+5K210116Video Endoscopy System, 3D Video Endoscopy SystemSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.20210—
+5K212667Single Use Guide Sheath Kit-401, K-402Olympus Medical Systems Corp.20210—
+5K210379Broncho Videoscope SystemScivita Medical Technology Co., Ltd.20213—
+5K202346SPiN Vision Video Bronchoscope SystemVeran Medical Technologies, Inc.20210—
+5K201758EVIS EXERA III Bronchovideoscope Olympus BF-XP190, EVIS EXERA III Bronchovideoscope…Olympus Medical Systems Corp.20211Class I
+5K201526TIPCAM1 Rubina Video Endoscope SystemKarl Storz Endoscopy America20205—
+5K202646Visera Elite II Video System CenterOlympus Medical Systems Corp.20200—
+5K192793Evis Exera III Colonovideoscope Olympus PCF-H190TL, Evis Exera III Colonovideoscope…Olympus Medical Systems Corp.202003
+5K192286FUJIFILM EP-6000 Video ProcessorFujifilm Corporation20200—
+5K192588G-EYE SystemSmart Medical Systems, Ltd.20202—
+5K193416Cellvizio I.V.E. with Confocal MiniprobesMauna Kea Technologies20200—
+5K192918Video Laparoscope, Video Processor, Light SourceFujifilm Corporation20206—
+5K191144Cellvizio 100 Series System with Confocal MiniprobesMauna Kea Technologies20202—
+5K193202EXALT Model D Single-Use Duodenoscope, EXALT ControllerBoston Scientific Corporation201946
+5K183640Cellvizio 100 Series Confocal laser Imaging systems and their Confocal MiniprobesMauna Kea Technologies20194—
+5K180668Single Use Aspiration Needle NA-U401SX-4025/NA-U401SX-4025NOlympus Medical Systems Corp.20180—
+5K181892Ziostation2Ziosoft, Inc.20181—
+5K181439SpyGlass DS and DS II Direct Visualization SystemBoston Scientific Corporation20187—
+5K163248Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration NeedleBoston Scientific Corporation20172—
+5K160275Fuse Endoscopic System with FuseBox ProcessorEndochoice, Inc.20160—
+5K160416CystoFlex UHD R-C, CelioFlex UHD 5-C, Cellvizio 100 Series (800) with Confocal MiniprobesMauna Kea Technologies20167—
+5K160229Echotip Ultra Endobronchial High Definition Ultrasound Needle, Echotip Procore…Cook Ireland, Ltd.20167—
+5K152922ViziShot FLEXSpiration, Inc.20166—
+5K133763Sonotip Pro and Pro Flex Ebus-Tbna Needle SystemMedi-Globe Corporation20142—
+5K131946Entax Ultrasound Video Bronchoscope EB-1970UK + HI Visin PreirusPentax Medical Company201434
+5K133385Lungpoint Atv Planning and Navigation SoftwareBroncus Medical, Inc.20140—
+5K071473Modification to Superdimension/Bronchus Premium 2Superdimension, Ltd.200753—
+6K261880FUJIFILM Processor EP-8000;Balloon Controller PB-30;Endoscopy Support Program EW10-VM01Fujifilm Corporation20260—
+6K252492Visualized Access and Delivery Catheter; PB Digital ControllerMicro-Tech (Nanjing) Co., Ltd.20260—
+6K250145Biopsy Port AdapterEndosound, Inc.20250—
+6K251752Flexible Bronchoscope (BS27U-12EU, BS27U-12US, BS38U-20EU, BS38U-20US)Shanghai AnQing Medical Instrument Co., Ltd.20250—
+6K243711Confocal Microprobe Imaging System (BrightP980); Confocal Microprobe Imaging System…Wuxi Hisky Medical Technologies Co., Ltd.20250—
+6K243261FUJIFILM Endoscope Model EC-860P/M; FUJIFILM Endoscope Model EC-860P/L; FUJIFILM…Fujifilm Corporation20250—
+6K250432Colonovideoscope (CF-EZ1500DL); Colonovideoscope (CF-EZ1500DI); Gastrointestinal…Olympus Medical Systems Corporation20250—
+6K250210Broncho Videoscope System (Single-use Broncho Videoscope (SBV-1A-B, SBV-1A-P, SBV-1B-B…Scivita Medical Technology Co., Ltd.20250—
+6K240289Full HD Endoscopic Image Processor (HDVS-S200A, HDVS-S200B, HDVS-S200C, HDVS-S200D)Scivita Medical Technology Co., Ltd.20240—
+6K241275Histolog® Scanner (Hardware 2.4, Software 3.3)Samantree Medical SA20240—
+6K233942PENTAX Medical Video Duodenoscope (ED34-i10T2s); PENTAX Medical Video Processor…Pentax of America, Inc.20240—
+6K233752Dragonfly™ Pancreaticobiliary Scope; Dragonfly™ Digital Controller; Dragonfly™…CenterPoint Systems, LLC20240—
+6K231521Broncho Videoscope SystemScivita Medical Technology Co., Ltd.20231—
+6K231267ClearTipFinemedix Co., Ltd.20231—
+6K223759Arthrex SynergyID Endoscopic Imaging SystemArthex, Inc.20234—
+6K213606EvoEndo Single-Use Endoscopy SystemEvoEndo, Inc.20223—
+6K212322Cellvizio I.V.E. system with Confocal MiniprobesMauna Kea Technologies20210—
+6K203717Processor VP-7000, Light Source BL-7000X, Image Processing Unit EX-0Fujifilm Corporaton20213—
+6K210476EchoTip Ultra Endoscopic Ultrasound Needle, EchoTip ProCore HD Ultrasound Biopsy Needle…Cook Ireland, Ltd.202121
+6K202469G-EYE SystemSmart Medical Systems, Ltd.20201—
+6K202130FUJIFILM Video LaparoscopeFujifilm Corporation20201—
+6K200315Ziostation2Ziosoft, Inc.20200—
+6K193517ViziShot 2 FLEXOlympus Surgical Technologies America20202Class I
+6K183516PENTAX Medical Ultrasound Video Bronchoscope EB19-J10UPentax of America, Inc.20191—
+6K183654PENTAX Medical EB-1970UK Ultrasound Video Bronchoscope + Hitachi NOBLUS and HI VISION…Pentax of America, Inc.20190—
+6K183085CoreDx™ Pulmonary Mini-ForcepsBoston Scientific Corporation20190—
+6K183636SpyScope DS Access and Delivery Catheter, SpyScope DS II Access and Delivery Catheter…Boston Scientific Corporation20195—
+6K171956Sterile Endoscope Biopsy Sampling NeedleChangzhou Detain Medical Devices Co., Ltd.20170—
+6K163469ViziShot 2 FLEXOlympus Surgical Technologies America20175—
+6K110093Superdimension Marker Delivery KitSuperdimension, Inc.20114—
+6K102604I-Logic Inreach SystemSuperdimension, Ltd.20108—
+6K080271Inreach SystemSuperdimension, Ltd.200852—
+7K261274EchoTip Ultra® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes; EchoTip…Cook Ireland, Ltd.20260—
+7K251338Cholangioscope Visualization System (Single-use Video Cholangioscope: SCV-P-01G…Scivita Medical Technology Co., Ltd.20260—
+7K251402LIA-1 Catheter (542-1)Leadoptik, Inc.20250—
+7K251708EvoEndo Single-Use Endoscopy SystemEvoEndo, Inc.20251—
+7K250994ClearTip FNA and FNB TypesFinemedix Co., Ltd.20250—
+7K250268HyperSnap Surgical System (HSS)Hypervision Surgical20251—
+7K250900EvoEndo Single-Use Endoscopy SystemEvoEndo, Inc.20250—
+7K241209EchoTip AcuCore™ EUS Biopsy Needle (ECHO-BX-19)Cook Ireland, Ltd.20240—
+7K233225SCHOELLY Oxygen Saturation Imaging (OSI) Camera System (Camera Control Unit, Camera Head…Schoelly Fiberoptic GmbH20240—
+7K233451Arthrex Synergy Vision Endoscopic Imaging SystemArthrex, Inc.20243—
+7K230909EchoTip® AcuCore™ Ultrasound Biopsy Needle (ECHO-BX-3-22)Cook Ireland, Ltd.20231—
+7K213060AreusTM Endobronchial Ultrasound Aspiration Needle, TridentTM Endobronchial Ultrasound…Micro-Tech (Nanjing) Co., Ltd.20221—
+7K220158G-EYE SystemSmart Medical Systems, Ltd.20220—
+7K212950FUJIFILM Video Laparoscope EL-R740M30Fujifilm Corporaton20210—
+7K203166PENTAX Medical Ultrasound Upper GI Video Scope EG34-J10U, PENTAX Medical Ultrasound…Pentax of America, Inc.20200—