510(k) Report

Devices descending from K931154

652 later devices reach Evis 200 System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K060243Olympus Guide Sheath, Model XBO1-836-13Olympus Medical Systems Corporation200611Class I
+1K033225Evis Exera Bronchofibervideoscope Olympus BF Type XP160F, Its Accessories and Ancillary…Olympus Optical Co., Ltd.2003605
+1K031256Xsif-1TQ140A Small Intestinal VideoscopeOlympus Opto-Electronics Co., Ltd.20035—
+1K022446Mucus Collection Probe, Models BC-401C & BC-402CAomori Olympus Co., Ltd.20030—
+1K021074Visera Cystovideoscope Olympus Cyf Type V/VAOlympus America, Inc.2002268—
+1K012073Olympus Spray Catheter PW-6C-1The Olympus Optical Co.20010—
+1K981543Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories and Ancillary…The Olympus Optical Co.19984315
+1K963033BF 240/P240/IT240 Bronchovideoscope & AccessoriesOlympus America, Inc.19965736
+1K962380Olympus BF Type 200 Video Bronchscopes (BF-200/BF-P200/BF-IT200)Olympus America, Inc.19960—
+1K954451Evis 140 SystemOlympus America, Inc.19963183
+2K254037LungFlow Airway CatheterFree Flow Medical, Inc.20260—
+2K250550FUJIFILM Endoscope Model EG-S100XT and VS-1000 Display UnitFujifilm Corporation20260—
+2K221631Tracheal Intubation Fiberscope OLYMPUS LF-P, VISERA Tracheal Intubation Videoscope…Olympus Medical Systems Corp.202204
+2K192164Single Use Guide Sheath Kit K-401, K-402, & Single Use Guiding Device CC-220DROlympus Medical Systems Corp.20201—
+2K172955LungVision ToolBodyvision Medical, Ltd.20181—
+2K171500Uro-V CystoscopeUroviu Corporation20185—
+2K160766Ambu USR, Ambu MAmbu A/S201614—
+2K130845Ambu Ascope 3 5.0/2.2; Ambu Ascope 3 Slim 3.8/1.2; Ambu AviewAmbu A/S201364—
+2K131234Lungpoint Tools (Lungpoint Sheath, Lungpoint Dilation Balloon)Broncus Medical, Inc.20135—
+2K123047Bracco Diagnostics Inc. CO2 Endoscopic Insufflator in Line Tubing SetBracco Diagnostic, Inc.20130—
+2K082720Tracheal Intubation Fibervideoscope, Models LF-Y0004 and LF-Y0005Olympus Medical Systems Corporation200813
+2K062049Evis Exera II 180 SystemOlympus Medical Systems Corporation2006158—
+2K051886Olympus Choledochoscope, Model XCHF-BP160FOlympus Medical Systems Corporation200513—
+2K051645Evis Exera 160A SystemOlympus Medical Systems Corporation20052083
+2K051176Flexible Video Cystoscope/Choledochoscope, Models 7308.061 and 7308.066Richard Wolf Medical Instruments Corp.20050—
+2K051551Small Intestinal Videoscope SystemOlympus Medical Systems Corporation20054—
+2K042140Olympus BF Type UC160-OL8Olympus Corporation2004431
+2K032177Gastrointestinal Videoscope Xgif-Q14OM, Xgif-2T140M Colonovideoscope XCF-Q14ML/I…Olympus Opto-Electronics Co., Ltd.200315—
+2K030960Ecn Electronic Video CystonephroscopeAcmi Corporation2003103—
+2K023984Modification to Olympus Bronchoscopes BF-40 Series, BF-240 Series, and BF-160 SeriesThe Olympus Optical Co.2003350Class I
+2K023259Inhealth Soft Sleeve Colonoscope Splint, Model CS1200Helix Medical, Inc.20026—
+2K021204Olympus BF Type UM40Olympus Optical Co., Ltd.200244—
+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—
+2K010591Olympus EU-C60 Eus Exera Compact Endoscopic Ultrasound CenterOlympus Optical Co., Ltd.2001592
+2K002231LF-DP Gastrointestinal and Sigmoid Fiberscope, Accessories and Ancillary EquipmentOlympus Optical Co., Ltd.200183—
+2K984358Olympus Distal Attachment, Models…Olympus America, Inc.1999302
+2K980465Olympus TJF-140R/JF-140R Evis Duodenovideoscopes and Accessories, Olympus…Olympus America, Inc.199822
+2K971660Olympus GF-UM130 Ultrasound Gastrovideoscope, Its Associated Accessories and Ancillary…Olympus America, Inc.1997752
+3K252050Disposable Biopsy Forceps FB-211D, FB-221D, FB-231D, FB-241DOlympus Medical Systems Corporation20260—
+3K251861FUJIFILM Endoscope Model ED-S100TP; FUJIFILM Endoscope Model ED-S100XP; FUJIFILM…Fujifilm Corporation20260—
+3K243388Disposable Distal CapMicro-Tech (Nanjing) Co., Ltd.20251—
+3K250296Disposable Distal Attachment D-201 SeriesOlympus Medical Systems Corp.20251—
+3K232601BroncTru™ Transbronchial Access ToolBroncus Medical, Inc.20240—
+3K221302Recon Steerable SheathSerpex Medical, Inc.20220—
+3K212667Single Use Guide Sheath Kit-401, K-402Olympus Medical Systems Corp.20210—
+3K202921Uro-G CystoscopeUroviu Corporation20213—
+3K201300Airway MobilescopeOlympus Medical Systems Corp.202102
+3K200702EasyPath RF Introducer SheathBroncus Medical, Inc.20210—
+3K200342Single Use Grasping Forceps FG-214P, Single Use Grasping Forceps FG-220P, Single Use…Olympus Medical Systems Corp.20200—
+3K193095Ambu aScope 4 CystoAmbu A/S202013—
+3K190972Ambu aScope 4 RhinoLaryngo InterventionAmbu A/S20192—
+3K182876Uro-N CystoscopeUroviu Corporation20190—
+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
+3K173004SB Soft Hood - Straight type, SB Soft Hood - Undercut typeSumitomo Bakelite Co., Ltd.20180—
+3K171673Focus CapGce Medical Corporation20180—
+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—
+3K152466Neo-Bronchoscope -Digital Video Bronchoscopy System (Rigid/Flexible)Prosurg, Inc.20160—
+3K142934CrossCountry Transbronchial Access Tool straight, CrossCountry Transbronchial Access…Covidien20152—
+3K150280PulmoVia Working ChannelSanovas, Inc.20150—
+3K133538Visera Cysto-Nephro Videoscope Olympus Cyf Type V2, Visera Cysto-Nephro Videoscope…Olympus Corporation of the Americas201425—
+3K123704Automated Endoscope Leak TesterOlympus Medical Systems Corp.20131—
+3K121959Evis Exera Iii Video SystemOlympus Medical Systems Corp.201314Class I
+3K113120CHF-Y0005Olympus Medical Systems Corp.20120—
+3K122565Arc EndocuffBoddingtons Plastics, Ltd.20124—
+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
+3K100624Invendo C20 Colonoscopy SystemInvendo Medical Gbmh20126—
+3K112680Evis Exera Iii Video SystemOlympus Medical Systems Corporation2012576
+3K101053Olympus CF Type Y0023-L, Y0023IOlympus Medical Systems Corporation20100—
+3K100584Evis Exeraii 180 SystemOlympus Medical Systems Corporation20101329
+3K093186Ambu Ascope and MonitorAmbu A/S20100—
+3K092221Colonic Splinting Overtube, Model 00711145United States Endoscopy Group, Inc.20095—
+3K091962Polyscope Flexible Endoscopy Catheter; 10,000 Pixel Fiber Optic; Xenon Light Source…Lumenis, Inc.200911—
+3K090170Spyscope Access and Delivery CatheterBoston Scientific Corp200910—
+3K071254Small Intestinal Videoscope SystemOlympus Medical Systems Corporation200831
+3K072957Evis Exera II 180 SystemOlympus Medical Systems Corporation2008171
+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—
+3K070330Third Eye Retroscope Auxiliary Endoscopy SystemAvantis Medical Systems, Inc.200713—
+3K063683Olympus Xeu-M60A Endoscopic Ultrasound Center; XGF-UM180 Ultrasonic GastrovideoscopeOlympus Medical Systems Corporation200715—
+3K061313Evis Exera 180 SystemOlympus Medical Systems Corporation2006158Class I
+3K052452Visera Rhino-Laryngovideoscope Olympus Enf Type VTOlympus Medical Systems Corporation2005159—
+3K051541GF-UE160-AL5 Ultrasound EndoscopeOlympus America, Inc.2005272
+3K050503Single Use Aspiration Needle NA-201SX-4022Olympus Medical Systems Corporation2005285
+3K050578Cook Ireland Duette Multi-Band Mucosectomy DeviceCook Ireland, Ltd.20054—
+3K050220Evis Exera Bronchovideoscope, Olympus XBF-160Y3AC, XBF-1T160Y3AC,XBF-Q160Y2ACOlympus Medical Systems Corporation20050Class I
+3K042438Superdimension/BronchusSuperdimension, Ltd.2004731
+3K040684T-Stat Microvascular Tissue Oximeter, Model 303Spectros Corporation200467—
+3K042069Invisio Irl Digital Rigid Laparoscope SystemAcmi Corporation20040—
+3K042225Acmi Invisio Icn, Models Icn-0564 and Icn-0565Acmi Corporation2004101—
+3K040940Bronchovideoscope Olympus XBF-D160HMOlympus Corporation200401
+3K031648Visera Rhino-Laryngovideoscope Olympus Enf Type VOlympus Optical Co., Ltd.2003159—
+3K032092Olympus Xcyf-TP3 Cystofiberscope/NephrofiberscopeOlympus Optical Co., Ltd.20030—
+3K031347Ultrasonic Gastrovideoscope, Type UC160P-AT8 and UCT160-AT8Olympus Optical Co., Ltd.200344—
+3K024033XTJF-160AF DuodenovideoscopeOlympus Optical Co., Ltd.200201
+3K021073Visera Rhinlaryngovideoscope Olympus Enf Type VOlympus America, Inc.2002160—
+3K011886Olympus EU-M60 Eus Exera Endoscopic Ultrasound CTR, Eus Exera Ultrasonic…Olympus America, Inc.2001601