510(k) Report

Devices descending from K963033

573 later devices reach BF 240/P240/IT240 Bronchovideoscope & Accessories through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K023984Modification to Olympus Bronchoscopes BF-40 Series, BF-240 Series, and BF-160 SeriesThe Olympus Optical Co.2003350Class I
+1K021204Olympus BF Type UM40Olympus Optical Co., Ltd.200244—
+1K010591Olympus EU-C60 Eus Exera Compact Endoscopic Ultrasound CenterOlympus Optical Co., Ltd.2001592
+1K981543Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories and Ancillary…The Olympus Optical Co.19984315
+2K221631Tracheal Intubation Fiberscope OLYMPUS LF-P, VISERA Tracheal Intubation Videoscope…Olympus Medical Systems Corp.202204
+2K130845Ambu Ascope 3 5.0/2.2; Ambu Ascope 3 Slim 3.8/1.2; Ambu AviewAmbu A/S201364—
+2K093186Ambu Ascope and MonitorAmbu A/S20100—
+2K082720Tracheal Intubation Fibervideoscope, Models LF-Y0004 and LF-Y0005Olympus Medical Systems Corporation200813
+2K063683Olympus Xeu-M60A Endoscopic Ultrasound Center; XGF-UM180 Ultrasonic GastrovideoscopeOlympus Medical Systems Corporation200715—
+2K061313Evis Exera 180 SystemOlympus Medical Systems Corporation2006158Class I
+2K050220Evis Exera Bronchovideoscope, Olympus XBF-160Y3AC, XBF-1T160Y3AC,XBF-Q160Y2ACOlympus Medical Systems Corporation20050Class I
+2K042438Superdimension/BronchusSuperdimension, Ltd.2004731
+2K042140Olympus BF Type UC160-OL8Olympus Corporation2004431
+2K040940Bronchovideoscope Olympus XBF-D160HMOlympus Corporation200401
+2K033225Evis Exera Bronchofibervideoscope Olympus BF Type XP160F, Its Accessories and Ancillary…Olympus Optical Co., Ltd.2003605
+2K031648Visera Rhino-Laryngovideoscope Olympus Enf Type VOlympus Optical Co., Ltd.2003159—
+2K031347Ultrasonic Gastrovideoscope, Type UC160P-AT8 and UCT160-AT8Olympus Optical Co., Ltd.200344—
+2K021074Visera Cystovideoscope Olympus Cyf Type V/VAOlympus America, Inc.2002268—
+2K013591Xenf-TP Rhino-Laryngofiberscope, Its Acessories and Ancillary EquipmentOlympus Optical Co., Ltd.2001176—
+2K011869Xenf-DP Rhino-Laryngofiberscope, Its Accessories and Ancillary EquipmentThe Olympus Optical Co.200182—
+2K002231LF-DP Gastrointestinal and Sigmoid Fiberscope, Accessories and Ancillary EquipmentOlympus Optical Co., Ltd.200183—
+3K252050Disposable Biopsy Forceps FB-211D, FB-221D, FB-231D, FB-241DOlympus Medical Systems Corporation20260—
+3K230280ANDORATE® Suction Valve and ANDORATE® Biopsy ValveGa Health Company Limited20230—
+3K220606Ambu aScope 5 Broncho HD 5.6/2.8, Ambu aScope 5 Broncho HD 5.0/2.2, Ambu aBox 2Ambu A/S202210—
+3K201300Airway MobilescopeOlympus Medical Systems Corp.202102
+3K200342Single Use Grasping Forceps FG-214P, Single Use Grasping Forceps FG-220P, Single Use…Olympus Medical Systems Corp.20200—
+3K183416Rhino-Laryngo Videoscope Olympus ENF-VT3Olympus Medical Systems Corp.201901
+3K190972Ambu aScope 4 RhinoLaryngo InterventionAmbu A/S20192—
+3K182102Rhino-Laryngo Videoscope Olympus Enf-VH2, Rhino-Laryngo Videoscope Olympus Enf-V4Olympus Medical Systems Corp.20191—
+3K183256GlideScope BFlex Single-Use Bronchoscope SystemVerathon Medical (Canada) Ulc20196—
+3K181286Ambu aScope RLS SlimAmbu A/S20186—
+3K181240Rhino-Laryngo Fiberscope Olympus ENF-GP2Olympus Medical Systems Corp.201811
+3K171500Uro-V CystoscopeUroviu Corporation20185—
+3K162151PENTAX Medical ENT Video Imaging SystemPentax of America, Inc.20176—
+3K161656Ambu aScope 3 Regular 5.0/2.2, Ambu aScope 3 Slim 3.8/1.2, Ambu aScope 3 Large 5.8/2.8…Ambu A/S201640—
+3K160766Ambu USR, Ambu MAmbu A/S201614—
+3K152466Neo-Bronchoscope -Digital Video Bronchoscopy System (Rigid/Flexible)Prosurg, Inc.20160—
+3K131028Pentax Video Bronchoscopes (EB Family)Pentax Medical Company201436
+3K121959Evis Exera Iii Video SystemOlympus Medical Systems Corp.201314Class I
+3K121564Endoscopic Ultrasound Center EU-Y0006Olympus Medical Systems Corp.20126—
+3K121035Fujinon/Fujifilm Ultrasonic Endoscope EB-530USFujifilm Medical System U.S.A., Inc.20122—
+3K111425Olympus LTF-S190-10, Olumpus Otv-S190, Olympus CLV-S190Olympus Medical Systems Corp.2012341
+3K100584Evis Exeraii 180 SystemOlympus Medical Systems Corporation20101329
+3K092156Cad 12, Colonoscopy Assist DeviceSoftscope Medical Technologies, Inc.20097—
+3K090095Lungpoint Virtual Bronchoscopic Navigation VBN SystemBroncus Technologies, Inc.20097—
+3K082174Y-AdapterAsthmatx, Inc.20080—
+3K080581VB Image ViewerOlympus Medical Systems Corporation20082—
+3K070983Olympus XBF-UC180F-DT8 Ultrasonic Bronchofibervideoscope Used with Aloka SSD-Alpha 5/10…Olympus Medical Systems Corporation2007113
+3K070752Ksea Miniature Endoscope, Model 11565KARL STORZ Endoscopy-America, Inc.20076—
+3K062049Evis Exera II 180 SystemOlympus Medical Systems Corporation2006158—
+3K061666Cellvizio with Confocal Miniprobes, Model F-600; Coloflex and GastroflexMauna Kea Technologies200613—
+3K051886Olympus Choledochoscope, Model XCHF-BP160FOlympus Medical Systems Corporation200513—
+3K051176Flexible Video Cystoscope/Choledochoscope, Models 7308.061 and 7308.066Richard Wolf Medical Instruments Corp.20050—
+3K052452Visera Rhino-Laryngovideoscope Olympus Enf Type VTOlympus Medical Systems Corporation2005159—
+3K052260Superdimension/Bronchus 4.1Superdimension, Ltd.2005562
+3K051585F-400 SystemMauna Kea Technologies200513—
+3K050503Single Use Aspiration Needle NA-201SX-4022Olympus Medical Systems Corporation2005285
+3K040684T-Stat Microvascular Tissue Oximeter, Model 303Spectros Corporation200467—
+3K032092Olympus Xcyf-TP3 Cystofiberscope/NephrofiberscopeOlympus Optical Co., Ltd.20030—
+3K030960Ecn Electronic Video CystonephroscopeAcmi Corporation2003103—
+3K021073Visera Rhinlaryngovideoscope Olympus Enf Type VOlympus America, Inc.2002160—
+4K260503Triton 1 SystemNeptune Medical, Inc.20260—
+4K260009LungPoint Virtual Bronchoscopic Navigation (VBN) SoftwareBroncus Medical, Inc.20260—
+4K252341Evis Exera Iii Bronchovideoscope (Olympus BF-Q190); Evis Exera Iii Bronchovideoscope…Olympus Medical Systems Corp.20260—
+4K250863FUJIFILM Ultrasonic Endoscope EB-710USFujifilm Corporation20250—
+4K243639Portare System (FA-001)Grumpy Innovation, Inc.20250—
+4K232043Endoscopic Video Image Processor (RP-IPD-V2000A, RP-IPD-V2000B, RP-IPD-V2000C…Guangzhou Red Pine Medical Instrument Co., Ltd.20240—
+4K2318541788 4K Camera System with Advanced Imaging Modality; L12 LED Light Source with AIMStryker20235—
+4K230332Ambu® aScope™ Colon; Ambu® aBox™ 2Ambu A/S20236—
+4K230588Aer-O-Scope Colonoscope SystemGi View, Ltd.20231—
+4K230428Ambu® aScope™ 5 Broncho 2.7/1.2, Ambu® aScope™ 5 Broncho 4.2/2.2, Ambu® aBox™ 2Ambu A/S20234—
+4K222861EVIS XI Video System Center Olympus CV-1500, Bronchovideoscope Olympus BF-H1100…Olympus Medical Systems Corporation20231—
+4K230536Single-use Flexible Rhinolaryngoscope; Digital Video MonitorHunan Vathin Medical Instrument Co., Ltd.20230—
+4K223299Ambu® aScope™ 5 Broncho HD 5.0/2.2, Ambu® aScope™ 5 Broncho HD 5.6/2.8, Ambu® aView™ 2…Ambu A/S202361
+4K221340iNod Ultrasound Guided Biopsy Needle (UPN: M00502060), iNod Ultrasound Guidance Console…Boston Scientific Corporation20230—
+4K223782Ambu aScope 5 Broncho HD 5.6/2.8 Sampler Set, Ambu aScope 5 Broncho HD 5.0/2.2 Sampler SetAmbu A/S20230—
+4K221660Rhino-Laryngofiberscope Olympus Enf Type-XPOlympus Medical Systems Corp.202201
+4K221581Single-Use Flexible RhinolaryngoscopeHunan Vathin Medical Instrument Co., Ltd.20220—
+4K221638Rhino-Laryngo Videoscope Olympus ENF-VH, Rhino-Laryngo Videoscope Olympus ENF-V3Olympus Medical Systems Corp.20220—
+4K210052Saneso Colonoscope 360-A (Model: with/without Select Band Imaging (SBI) and with/without…Saneso, Inc.20221—
+4K212382Ambu® aScope™ Gastro, Ambu® aBox™2Ambu A/S20222—
+4K211947GlideScope BFlex 2.8 Single-Use BronchoscopeVerathon Medical (Canada) Ulc20213—
+4K210928PENTAX Medical Video Bronchoscope EB11-J10Pentax of America, Inc.20210—
+4K202921Uro-G CystoscopeUroviu Corporation20213—
+4K201617TipVision Videoscope System (TipVision VideoScope 0°/30°; EleVision HD 2 Camera Control…Schoelly Fiberoptic GmbH20210—
+4K203128Evis Eus Endoscopic Ultrasound Center Olympus EU-ME2/Evis Eus Endoscopic Ultrasound…Olympus Medical Systems Corp.20201—
+4K192704Endofresh Digestive Endoscopy SystemHuizhou Xzing Technology Co., Ltd.20200—
+4K200678PENTAX Medical Video Bronchoscope EB-J10 SeriesPentax of America, Inc.20200—
+4K201098Ambu Duodeno SystemAmbu Innovation GmbH20202—
+4K193026Visera Elite II Video System Center, Visera Elite II Endoeye 3DOlympus Medical Systems Corp.20205—
+4K193095Ambu aScope 4 CystoAmbu A/S202013—
+4K193488GlideScope BFlex 3.8 Single-Use BronchoscopeVerathon Medical (Canada) Ulc20204—
+4K183525EVIS EUS Ultrasound Bronchofibervideoscope Olympus BF-UC190FOlympus Medical Systems Corp.201921
+4K190449Visera Elite II Video System Center, Visera Elite II HD 3CMOS Autoclavable Camera Head…Olympus Medical Systems Corp.20195—
+4K191948GlideScope BFlex 5.8 Single-Use BronchoscopeVerathon Medical (Canada) Ulc20195—
+4K182876Uro-N CystoscopeUroviu Corporation20190—
+4K183691PENTAX Medical ENT Video Imaging SystemPentax of America, Inc.20192—
+4K191080Ambu aScope 4 RhinoLaryngo SlimAmbu A/S20194—
+4K182825FUJIFILM Ultrasonic EndoscopeFujifilm Corporation20190—
+4K173921HD-500 Video Endoscope SystemSonoscape Medical Corp.20182—