510(k) Report

Devices descending from K910423

352 later devices reach Bronchoscope BF-N20 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—
+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
+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—
+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
+3K183416Rhino-Laryngo Videoscope Olympus ENF-VT3Olympus Medical Systems Corp.201901
+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—
+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
+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
+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
+3K061666Cellvizio with Confocal Miniprobes, Model F-600; Coloflex and GastroflexMauna Kea Technologies200613—
+3K051886Olympus Choledochoscope, Model XCHF-BP160FOlympus Medical Systems Corporation200513—
+3K052260Superdimension/Bronchus 4.1Superdimension, Ltd.2005562
+3K051585F-400 SystemMauna Kea Technologies200513—
+3K050503Single Use Aspiration Needle NA-201SX-4022Olympus Medical Systems Corporation2005285
+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—
+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—
+4K223299Ambu® aScope™ 5 Broncho HD 5.0/2.2, Ambu® aScope™ 5 Broncho HD 5.6/2.8, Ambu® aView™ 2…Ambu A/S202361
+4K223782Ambu aScope 5 Broncho HD 5.6/2.8 Sampler Set, Ambu aScope 5 Broncho HD 5.0/2.2 Sampler SetAmbu A/S20230—
+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—
+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—
+4K183691PENTAX Medical ENT Video Imaging SystemPentax of America, Inc.20192—
+4K182825FUJIFILM Ultrasonic EndoscopeFujifilm Corporation20190—
+4K173921HD-500 Video Endoscope SystemSonoscape Medical Corp.20182—
+4K172726EVIS EXERA III BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-MP190F, Single Use Biopsy Forceps FB-433DOlympus Medical Systems Corp.201872
+4K172156PENTAX Medical EPK-3000 Video Imaging SystemPentax Medical20183—
+4K173727Ambu aScope 3 Slim 3.8/1.2 and Ambu aScope 4 Broncho Slim 3.8/1.2; Ambu aScope 3 Regular…Ambu A/S201839—
+4K173554PENTAX Medical Video Bronchoscopes, PENTAX Medical Video Naso-Pharyngo-Laryngoscope, and…Pentax of America, Inc.20180—
+4K173085invendoscopy E210 SystemInvendo Medical GmbH20180—
+4K161355invendoscopy E200 SystemInvendo Medical GmbH20161—
+4K160098Single Use Aspiration Needle NA-U401SXOlympus Medical Systems Corp.201612
+4K151315Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration NeedleBoston Scientific Corporation20153—
+4K143727PENTAX Medical EKP-i5010 Video Processor with EB FamilyPentax of America, Inc.20153—
+4K151895Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration NeedleBoston Scientific Corporation20150—
+4K151011Visera 4K Uhd SystemOlympus Medical Systems Corp.20153—
+4K142909Flexible 19G EBUS NeedleSpiration, Inc.20157—
+4K140149Epx-4440HD Digital Video ProcessorFujifilm Medical Systems U.S.A, Inc.201416—
+4K133466Cellvizio 100 Series System with Confocal Miniprobes (TM)Mauna Kea Technologies20147—
+4K131902Pentax Video Upper G.I. Scopes (EG Family)Pentax Medical Company2014102
+4K131855Pentax Video Colonoscopes (EC Family)Pentax Medical Company2014136
+4K131422Peerscope SystemEndochoice, Inc.20132—
+4K122470Pentax Epk-I5010 Video ProcessorPentax Medical20136—
+4K123365Olympus LTF-190-10-3D, Maj-Y0154, Olympus CV-190Olympus Medical Systems Corp.201319—
+4K123704Automated Endoscope Leak TesterOlympus Medical Systems Corp.20131—
+4K123317Evis Exera Iii Gastrointestinal Videoscope Olympus GIXP190NOlympus Medical Systems Corporation20120—
+4K113120CHF-Y0005Olympus Medical Systems Corp.20120—
+4K111756V1 SystemOlympus Medical Systems Corp.201202
+4K112680Evis Exera Iii Video SystemOlympus Medical Systems Corporation2012576
+4K111047Cellvizio 100 Series System with Confocal MiniprobesMauna Kea Technologies, Inc.201112—
+4K093810BF-NaviKgt, Inc.20101—
+4K093195Echotip Ultra Endobronchial High Definition Ultasound Needle, Model: Echo-HD-22-Ebus-OCook Ireland, Ltd.20108—
+4K091257Medi-Globe Sonotip II Ebus-Tbna Needle SystemMedi-Globe Corporation20093—
+4K091160Lungpoint Virtual Bronchoscopic Navigation VBN SystemBroncus Technologies, Inc.20095—
+4K090170Spyscope Access and Delivery CatheterBoston Scientific Corp200910—
+4K081518Ultrasound Video Bronchoscope, Model EB-1970UKPentax Medical Company20085—
+4K052852Superdimension/Bronchus PremiumSuperdimension, Ltd.2005551
+5K261400Ambu® aScope™ Gastro; Ambu® aScope™ Gastro LargeAmbu A/S20260—