510(k) Report

Devices descending from K910423

352 later devices reach Bronchoscope BF-N20 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K062315Superdimension/Bronchus Premium 2Superdimension, Ltd.2006541
+6K261637Single-use Flexible BronchoscopeHunan Vathin Medical Instrument Co., Ltd.20260—
+6K260309Ambu® aScope™ 5 Broncho 2.7/1.2; Ambu® aScope™ 5 Broncho 4.2/2.2; Ambu® aScope™ 5…Ambu A/S20260—
+6K2620794K Camera Head OLYMPUS CH-S700-08-LBOlympus Medical Systems Corp.20260—
+6K254153Single-use Video Scope; PB Digital ControllerMirco-Tech (Nanjing) Co., Ltd.20260—
+6K251861FUJIFILM Endoscope Model ED-S100TP; FUJIFILM Endoscope Model ED-S100XP; FUJIFILM…Fujifilm Corporation20260—
+6K2601851688 4K Camera System with Advanced Imaging Modality; 1788 4K Camera System with…Stryker Endoscopy20260—
+6K251336VISERA ELITE III Video System Center Olympus OTV-S700 (OTV-S700); VISERA ELITE III Light…Olympus Medical Systems Corp.20250—
+6K250145Biopsy Port AdapterEndosound, Inc.20250—
+6K251986Auxiliary Water Tube Maj-855Olympus Medical Systems Corporation20250—
+6K252598Flexible Cystoscope (CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US)Shanghai AnQing Medical Instrument Co., Ltd.20250—
+6K250939SIRIUS Endoscope System (PR-SI-1230)Precision Robotics (Hong Kong) Limited20250—
+6K244017FUJIFILM Endoscope Model EB-710P; FUJIFILM Processor EP-8000Fujifilm Corporation20250—
+6K251127PENTAX Medical Video Processor (EPK-i8020c)Pentax of America, Inc.202501
+6K243497Portable Video Processor (EA101), Flexible Bronchoscope BS41H-12EU, BS41H-12US…Shanghai AnQing Medical Instrument Co., Ltd.20251—
+6K243541LumiRex BronchoscopeContra Healthcare Solutions, LLC20250—
+6K243260FUJIFILM Processor EP-8000; FUJIFILM Endoscope Model EG-860RFujifilm Corporation20251—
+6K242010Bronchoscope System, The Single-use Bronchoscope (Single-use Bronchoscope: SP-Y-ZQGJ2.8…Shenzhen Sanping Image Technology Co., Ltd.20250—
+6K243380Visera S Video System Center Olympus Otv-S500 (Olympus Otv-S500)Olympus Medical Systems Corporation20250—
+6K241444Biliary Pancreaticobiliary Scope SystemShenzhen HugeMed Medical Technical Development Co., Ltd.20250—
+6K242108Ambu® aScope™ 5 Uretero (Standard Deflection); Ambu® aScope™ 5 Uretero (Reverse…Ambu A/S20240—
+6K241371Visera S Video System Center Olympus Otv-S500 (Olympus Otv-S500)Olympus Medical Systems Corporation20240—
+6K240283BubbleView™ Single-Use Digital Flexible Cystoscope (C50-C, C50-CR, C50-CB, C50-CBR)…MacroLux Medical Technology Co., Ltd.20240—
+6K231107Bronchoscope SystemHunan Endoso Life Technology Co., Ltd.20241—
+6K232860PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Bronchoscope EB11-J10…Pentax of America, Inc.20241—
+6K231970PENTAX Medical Single Use Video Bronchoscope EB11-S01, PENTAX Medical Single Use Video…Pentax of America, Inc.20240—
+6K232249PENTAX Medical Gas/Water Feeding Valve OE-B14Pentax of America, Inc.20230—
+6K232244Disposable Endoscope Valves SystemChangzhou Endoclean Medical Device Co., Ltd.20230—
+6K232028Q Vision Sterile Single Use Adult Flexible Gastroscope (G-100); Q Base Reusable Base…Iq Endoscopes Limited20230—
+6K231702WiScope® Digital Cystoscope System, WiScope® Single-Use Digital Flexible Cystoscope…OTU Medical, Inc.20230—
+6K231267ClearTipFinemedix Co., Ltd.20231—
+6K222584Evis X1 Video System Center Olympus CV-1500, Colonovideoscope Olympus CF-HQ1100DL/I…Olympus Medical Systems Corporation202321
+6K221784Single-use Video Pancreaticobiliary Scope, PB Digital ControllerMicro-Tech (Nanjing) Co., Ltd.20232—
+6K222020HD-550 Video Endoscope SystemSonoscape Medical Corp.20220—
+6K222014EXALT Model B Single-Use BronchoscopeBoston Scientific Corporation20220—
+6K212886Broncoflex Agile, Broncoflex Vortex, ScreeniAxess Vision Technology20220—
+6K210116Video Endoscopy System, 3D Video Endoscopy SystemSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.20210—
+6K212667Single Use Guide Sheath Kit-401, K-402Olympus Medical Systems Corp.20210—
+6K210379Broncho Videoscope SystemScivita Medical Technology Co., Ltd.20213—
+6K210476EchoTip Ultra Endoscopic Ultrasound Needle, EchoTip ProCore HD Ultrasound Biopsy Needle…Cook Ireland, Ltd.202121
+6K202346SPiN Vision Video Bronchoscope SystemVeran Medical Technologies, Inc.20210—
+6K201758EVIS EXERA III Bronchovideoscope Olympus BF-XP190, EVIS EXERA III Bronchovideoscope…Olympus Medical Systems Corp.20211Class I
+6K201526TIPCAM1 Rubina Video Endoscope SystemKarl Storz Endoscopy America20205—
+6K202646Visera Elite II Video System CenterOlympus Medical Systems Corp.20200—
+6K192793Evis Exera III Colonovideoscope Olympus PCF-H190TL, Evis Exera III Colonovideoscope…Olympus Medical Systems Corp.202003
+6K192286FUJIFILM EP-6000 Video ProcessorFujifilm Corporation20200—
+6K192588G-EYE SystemSmart Medical Systems, Ltd.20202—
+6K193517ViziShot 2 FLEXOlympus Surgical Technologies America20202Class I
+6K193416Cellvizio I.V.E. with Confocal MiniprobesMauna Kea Technologies20200—
+6K192918Video Laparoscope, Video Processor, Light SourceFujifilm Corporation20206—
+6K191144Cellvizio 100 Series System with Confocal MiniprobesMauna Kea Technologies20202—
+6K193202EXALT Model D Single-Use Duodenoscope, EXALT ControllerBoston Scientific Corporation201946
+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—
+6K183640Cellvizio 100 Series Confocal laser Imaging systems and their Confocal MiniprobesMauna Kea Technologies20194—
+6K181892Ziostation2Ziosoft, Inc.20181—
+6K181439SpyGlass DS and DS II Direct Visualization SystemBoston Scientific Corporation20187—
+6K171956Sterile Endoscope Biopsy Sampling NeedleChangzhou Detain Medical Devices Co., Ltd.20170—
+6K163469ViziShot 2 FLEXOlympus Surgical Technologies America20175—
+6K160275Fuse Endoscopic System with FuseBox ProcessorEndochoice, Inc.20160—
+6K160416CystoFlex UHD R-C, CelioFlex UHD 5-C, Cellvizio 100 Series (800) with Confocal MiniprobesMauna Kea Technologies20167—
+6K133385Lungpoint Atv Planning and Navigation SoftwareBroncus Medical, Inc.20140—
+6K071473Modification to Superdimension/Bronchus Premium 2Superdimension, Ltd.200753—
+7K261274EchoTip Ultra® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes; EchoTip…Cook Ireland, Ltd.20260—
+7K261880FUJIFILM Processor EP-8000;Balloon Controller PB-30;Endoscopy Support Program EW10-VM01Fujifilm Corporation20260—
+7K252492Visualized Access and Delivery Catheter; PB Digital ControllerMicro-Tech (Nanjing) Co., Ltd.20260—
+7K251402LIA-1 Catheter (542-1)Leadoptik, Inc.20250—
+7K251752Flexible Bronchoscope (BS27U-12EU, BS27U-12US, BS38U-20EU, BS38U-20US)Shanghai AnQing Medical Instrument Co., Ltd.20250—
+7K250994ClearTip FNA and FNB TypesFinemedix Co., Ltd.20250—
+7K243711Confocal Microprobe Imaging System (BrightP980); Confocal Microprobe Imaging System…Wuxi Hisky Medical Technologies Co., Ltd.20250—
+7K243261FUJIFILM Endoscope Model EC-860P/M; FUJIFILM Endoscope Model EC-860P/L; FUJIFILM…Fujifilm Corporation20250—
+7K250432Colonovideoscope (CF-EZ1500DL); Colonovideoscope (CF-EZ1500DI); Gastrointestinal…Olympus Medical Systems Corporation20250—
+7K250210Broncho Videoscope System (Single-use Broncho Videoscope (SBV-1A-B, SBV-1A-P, SBV-1B-B…Scivita Medical Technology Co., Ltd.20250—
+7K240289Full HD Endoscopic Image Processor (HDVS-S200A, HDVS-S200B, HDVS-S200C, HDVS-S200D)Scivita Medical Technology Co., Ltd.20240—
+7K241275Histolog® Scanner (Hardware 2.4, Software 3.3)Samantree Medical SA20240—
+7K233942PENTAX Medical Video Duodenoscope (ED34-i10T2s); PENTAX Medical Video Processor…Pentax of America, Inc.20240—
+7K241209EchoTip AcuCore™ EUS Biopsy Needle (ECHO-BX-19)Cook Ireland, Ltd.20240—
+7K233752Dragonfly™ Pancreaticobiliary Scope; Dragonfly™ Digital Controller; Dragonfly™…CenterPoint Systems, LLC20240—
+7K231521Broncho Videoscope SystemScivita Medical Technology Co., Ltd.20231—
+7K230909EchoTip® AcuCore™ Ultrasound Biopsy Needle (ECHO-BX-3-22)Cook Ireland, Ltd.20231—
+7K223759Arthrex SynergyID Endoscopic Imaging SystemArthex, Inc.20234—
+7K213060AreusTM Endobronchial Ultrasound Aspiration Needle, TridentTM Endobronchial Ultrasound…Micro-Tech (Nanjing) Co., Ltd.20221—
+7K213606EvoEndo Single-Use Endoscopy SystemEvoEndo, Inc.20223—
+7K212322Cellvizio I.V.E. system with Confocal MiniprobesMauna Kea Technologies20210—
+7K203717Processor VP-7000, Light Source BL-7000X, Image Processing Unit EX-0Fujifilm Corporaton20213—
+7K203166PENTAX Medical Ultrasound Upper GI Video Scope EG34-J10U, PENTAX Medical Ultrasound…Pentax of America, Inc.20200—
+7K202469G-EYE SystemSmart Medical Systems, Ltd.20201—
+7K202130FUJIFILM Video LaparoscopeFujifilm Corporation20201—
+7K200315Ziostation2Ziosoft, Inc.20200—
+7K190239Single Use Aspiration NeedleOlympus Medical Systems Corp.20192—
+7K183636SpyScope DS Access and Delivery Catheter, SpyScope DS II Access and Delivery Catheter…Boston Scientific Corporation20195—
+7K110093Superdimension Marker Delivery KitSuperdimension, Inc.20114—
+7K102604I-Logic Inreach SystemSuperdimension, Ltd.20108—
+7K080271Inreach SystemSuperdimension, Ltd.200852—
+8K251478ClearTip TBNA TypeFinemedix Co., Ltd.20260—
+8K251338Cholangioscope Visualization System (Single-use Video Cholangioscope: SCV-P-01G…Scivita Medical Technology Co., Ltd.20260—
+8K251708EvoEndo Single-Use Endoscopy SystemEvoEndo, Inc.20251—
+8K251664Single Use Aspiration Needle (NA-201SX-4021); Single Use Aspiration Needle (NA-201SX-4022)Olympus Medical Systems Corporation20250—
+8K250268HyperSnap Surgical System (HSS)Hypervision Surgical20251—