510(k) Report

Devices descending from K931154

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K260503Triton 1 SystemNeptune Medical, Inc.20260—
+4K260856Disposable Distal Attachment D-201-13404Olympus Medical Systems Corporation20260—
+4K260565SmartClip Delivery Catheter (ADR-1715)Elucent Medical20260—
+4K252341Evis Exera Iii Bronchovideoscope (Olympus BF-Q190); Evis Exera Iii Bronchovideoscope…Olympus Medical Systems Corp.20260—
+4K253139Disposable Distal CapMirco-Tech (Nanjing) Co., Ltd.20260—
+4K250863FUJIFILM Ultrasonic Endoscope EB-710USFujifilm Corporation20250—
+4K251859EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190)Olympus Medical Systems Corporation20251—
+4K251140Zenflow Spring ScopeZenflow, Inc.20250—
+4K243639Portare System (FA-001)Grumpy Innovation, Inc.20250—
+4K242535Single-use Flexible Cystoscope (CY-E2E01, CY-E2E01R, CY-E2F01, CY-E2F01R, CY-E2G01…Hunan Vathin Medical Instrument Co., Ltd.20240—
+4K240849Ambu® aScope™ 5 Cysto HD (Standard Deflection); Ambu® aScope™ 5 Cysto HD (Reverse…Ambu A/S20240—
+4K240227LiNA CystoVu™ HD (CYV-100-5; CYV-101-5); LiNA ScopeVu™ (SCP-100-1)Lina Medical Aps20240—
+4K241500Endoscopic Video Image Processor (RP-IPD-V2000EF); Single-Use Video Flexible…Guangzhou Red Pine Medical Instrument Co., Ltd.20242—
+4K232997EVIS Exera III Gastrointestinal Videoscope GIF-1TH190Olympus Medical Systems Corporation202412
+4K232837Uro-G HD Flexible CystoscopeUroviu Corporation20242—
+4K232043Endoscopic Video Image Processor (RP-IPD-V2000A, RP-IPD-V2000B, RP-IPD-V2000C…Guangzhou Red Pine Medical Instrument Co., Ltd.20240—
+4K231118Cystoscope SystemShenzhen HugeMed Medical Technical Development Co., Ltd.20230—
+4K223926VersaVue Single-Use Flexible Cystoscope, VersaVue Tablet, and VersaVue Video BoxMedimaging Integrated Solution, Inc (Miis)20230—
+4K2318541788 4K Camera System with Advanced Imaging Modality; L12 LED Light Source with AIMStryker20235—
+4K230332Ambu® aScope™ Colon; Ambu® aBox™ 2Ambu A/S20236—
+4K231323Ancora-SBAspero Medical, Inc.20231—
+4K230588Aer-O-Scope Colonoscope SystemGi View, Ltd.20231—
+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—
+4K230280ANDORATE® Suction Valve and ANDORATE® Biopsy ValveGa Health Company Limited20230—
+4K221683CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-V2), CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-V2R)…Olympus Medical Systems Corporation202315
+4K221690Oes Cystonephro Fiberscope (Olympus Cyf-5), Oes Cystonephro Fiberscope (Olympus Cyf-5R)…Olympus Medical Systems Corp.202203
+4K221660Rhino-Laryngofiberscope Olympus Enf Type-XPOlympus Medical Systems Corp.202201
+4K221581Single-Use Flexible RhinolaryngoscopeHunan Vathin Medical Instrument Co., Ltd.20220—
+4K221580Single-Use Flexible CystoscopeHunan Vathin Medical Instrument Co., Ltd.20220—
+4K222162Flexible Cystoscope (Model: CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US)Shanghai AnQing Medical Instrument Co., Ltd.20221—
+4K222602Pusen Single Use Flexible Video Cystoscope System (Single Use Flexible Video Cystoscope…Zhuhai Pusen Medical Technology Co., Ltd.20221—
+4K220606Ambu aScope 5 Broncho HD 5.6/2.8, Ambu aScope 5 Broncho HD 5.0/2.2, Ambu aBox 2Ambu A/S202210—
+4K212202WiScope Digital Cystoscope System, WiScope Single-Use Digital Flexible Cystoscope…OTU Medical, Inc.20221—
+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—
+4K212201PENTAX Medical Auto Leakage Tester SHA-P6Pentax 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—
+4K201098Ambu Duodeno SystemAmbu Innovation GmbH20202—
+4K193026Visera Elite II Video System Center, Visera Elite II Endoeye 3DOlympus Medical Systems Corp.20205—
+4K193488GlideScope BFlex 3.8 Single-Use BronchoscopeVerathon Medical (Canada) Ulc20204—
+4K183416Rhino-Laryngo Videoscope Olympus ENF-VT3Olympus Medical Systems Corp.201901
+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—
+4K191080Ambu aScope 4 RhinoLaryngo SlimAmbu A/S20194—
+4K182723Flexible HD Cysto-Urethroscope SystemKARL STORZ Endoscopy-America, Inc.20193—
+4K182825FUJIFILM Ultrasonic EndoscopeFujifilm Corporation20190—
+4K182102Rhino-Laryngo Videoscope Olympus Enf-VH2, Rhino-Laryngo Videoscope Olympus Enf-V4Olympus Medical Systems Corp.20191—
+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
+4K172246Olympus Urf-V2/V2ROlympus Medical Systems Corp.201823
+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—
+4K173085invendoscopy E210 SystemInvendo Medical GmbH20180—
+4K162151PENTAX Medical ENT Video Imaging SystemPentax of America, Inc.20176—
+4K162205Arc EndoCuff and Arc EndoCuff VisionBoddingtons Plastics, Ltd.20160—
+4K161355invendoscopy E200 SystemInvendo Medical GmbH20161—
+4K161791Aer-O-Scope Colonoscope SystemGi View, Ltd.20160—
+4K160846AmplifEYEMedivators, Inc.20160—
+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—
+4K142922SpyGlass DS Direct Visualization SystemBoston Scientific Corporation201591
+4K140595Third Eye Panoramic Auxiliary Endoscopy SystemAvantis Medical Systems, Inc.20142—
+4K141286Aer-O-Scope Colonoscope SystemGi View, Ltd.20142—
+4K140149Epx-4440HD Digital Video ProcessorFujifilm Medical Systems U.S.A, Inc.201416—
+4K140726Captivator Emr Device for Standard Gastroscopes - Box 1, Captivator Emr Device for…Boston Scientific Corp20142—
+4K131028Pentax Video Bronchoscopes (EB Family)Pentax Medical Company201436
+4K131902Pentax Video Upper G.I. Scopes (EG Family)Pentax Medical Company2014102
+4K131855Pentax Video Colonoscopes (EC Family)Pentax Medical Company2014136
+4K132389Cellvizio 100 Series System and Cellvizio System with Confocal Miniprobes; Uroflex B and…Daniel & Daniel Consulting201410—
+4K133359EndoringsEndo-Aid, Inc.20141—
+4K131422Peerscope SystemEndochoice, Inc.20132—
+4K131780Evis Exera Iii Video SystemOlympus Medical Systems Corp.201378
+4K122470Pentax Epk-I5010 Video ProcessorPentax Medical20136—
+4K123013Endoscopic IntroducerNovadaq Technologies, Inc.20130—
+4K123365Olympus LTF-190-10-3D, Maj-Y0154, Olympus CV-190Olympus Medical Systems Corp.201319—
+4K121582Invendo C25 Colonoscopy SystemInvendo Medical Gbmh20125—
+4K122831Video System CenterOlympus Medical Systems Corp.201219—
+4K123317Evis Exera Iii Gastrointestinal Videoscope Olympus GIXP190NOlympus Medical Systems Corporation20120—
+4K121564Endoscopic Ultrasound Center EU-Y0006Olympus Medical Systems Corp.20126—
+4K112826Noorvms-Oxy Tissue Oxygen and Temperture MonitorMoor Instruments, Ltd.20120—
+4K111756V1 SystemOlympus Medical Systems Corp.201202
+4K103155Sumo Access and Tissue Resection SystemApollo Endosurgery, Inc.20110—
+4K100081Enteroscopy Overtube, Model 00712140United States Endoscopy Group, Inc.20103—
+4K093195Echotip Ultra Endobronchial High Definition Ultasound Needle, Model: Echo-HD-22-Ebus-OCook Ireland, Ltd.20108—
+4K092156Cad 12, Colonoscopy Assist DeviceSoftscope Medical Technologies, Inc.20097—
+4K091759Single Use Splinting Tube, Models ST-Y0002-S, ST-Y0002-H, ST-Y0003-S and ST-Y0003-HOlympus Medical Systems Corporation20090—
+4K091452Fore-Sight, Model MC-2000 Series (MC 2000, MC2010, MC-2020,MC2030)Cas Medical Systems, Inc.200957—
+4K091257Medi-Globe Sonotip II Ebus-Tbna Needle SystemMedi-Globe Corporation20093—
+4K090814Modification to Gyrus Acmi Invisio Icn, Models Icn-0564 and Icn-0565Gyrus Acmi, Inc.20090—
+4K083892Fore-Sight, Model MC-2000 Series (MC-2000, MC-2010, MC2020, MC2030)Cas Medical Systems, Inc.200958—
+4K090095Lungpoint Virtual Bronchoscopic Navigation VBN SystemBroncus Technologies, Inc.20097—
+4K083180Third Eye Retroscope Auxiliary Endoscopy SystemAvantis Medical Systems, Inc.20095—