510(k) Report

Devices descending from K051645

208 later devices reach Evis Exera 160A System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K121959Evis Exera Iii Video SystemOlympus Medical Systems Corp.201314Class I
+1K100624Invendo C20 Colonoscopy SystemInvendo Medical Gbmh20126—
+1K112680Evis Exera Iii Video SystemOlympus Medical Systems Corporation2012576
+1K101053Olympus CF Type Y0023-L, Y0023IOlympus Medical Systems Corporation20100—
+1K100584Evis Exeraii 180 SystemOlympus Medical Systems Corporation20101329
+1K091962Polyscope Flexible Endoscopy Catheter; 10,000 Pixel Fiber Optic; Xenon Light Source…Lumenis, Inc.200911—
+1K072957Evis Exera II 180 SystemOlympus Medical Systems Corporation2008171
+1K062049Evis Exera II 180 SystemOlympus Medical Systems Corporation2006158—
+1K061313Evis Exera 180 SystemOlympus Medical Systems Corporation2006158Class I
+2K260503Triton 1 SystemNeptune Medical, Inc.20260—
+2K252341Evis Exera Iii Bronchovideoscope (Olympus BF-Q190); Evis Exera Iii Bronchovideoscope…Olympus Medical Systems Corp.20260—
+2K251861FUJIFILM Endoscope Model ED-S100TP; FUJIFILM Endoscope Model ED-S100XP; FUJIFILM…Fujifilm Corporation20260—
+2K250550FUJIFILM Endoscope Model EG-S100XT and VS-1000 Display UnitFujifilm Corporation20260—
+2K232997EVIS Exera III Gastrointestinal Videoscope GIF-1TH190Olympus Medical Systems Corporation202412
+2K232043Endoscopic Video Image Processor (RP-IPD-V2000A, RP-IPD-V2000B, RP-IPD-V2000C…Guangzhou Red Pine Medical Instrument Co., Ltd.20240—
+2K230332Ambu® aScope™ Colon; Ambu® aBox™ 2Ambu A/S20236—
+2K230588Aer-O-Scope Colonoscope SystemGi View, Ltd.20231—
+2K222861EVIS XI Video System Center Olympus CV-1500, Bronchovideoscope Olympus BF-H1100…Olympus Medical Systems Corporation20231—
+2K230280ANDORATE® Suction Valve and ANDORATE® Biopsy ValveGa Health Company Limited20230—
+2K220606Ambu aScope 5 Broncho HD 5.6/2.8, Ambu aScope 5 Broncho HD 5.0/2.2, Ambu aBox 2Ambu A/S202210—
+2K210052Saneso Colonoscope 360-A (Model: with/without Select Band Imaging (SBI) and with/without…Saneso, Inc.20221—
+2K212382Ambu® aScope™ Gastro, Ambu® aBox™2Ambu A/S20222—
+2K192704Endofresh Digestive Endoscopy SystemHuizhou Xzing Technology Co., Ltd.20200—
+2K201098Ambu Duodeno SystemAmbu Innovation GmbH20202—
+2K183416Rhino-Laryngo Videoscope Olympus ENF-VT3Olympus Medical Systems Corp.201901
+2K182102Rhino-Laryngo Videoscope Olympus Enf-VH2, Rhino-Laryngo Videoscope Olympus Enf-V4Olympus Medical Systems Corp.20191—
+2K173921HD-500 Video Endoscope SystemSonoscape Medical Corp.20182—
+2K172726EVIS EXERA III BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-MP190F, Single Use Biopsy Forceps FB-433DOlympus Medical Systems Corp.201872
+2K172246Olympus Urf-V2/V2ROlympus Medical Systems Corp.201823
+2K173085invendoscopy E210 SystemInvendo Medical GmbH20180—
+2K162151PENTAX Medical ENT Video Imaging SystemPentax of America, Inc.20176—
+2K161355invendoscopy E200 SystemInvendo Medical GmbH20161—
+2K161791Aer-O-Scope Colonoscope SystemGi View, Ltd.20160—
+2K143727PENTAX Medical EKP-i5010 Video Processor with EB FamilyPentax of America, Inc.20153—
+2K141286Aer-O-Scope Colonoscope SystemGi View, Ltd.20142—
+2K140149Epx-4440HD Digital Video ProcessorFujifilm Medical Systems U.S.A, Inc.201416—
+2K133538Visera Cysto-Nephro Videoscope Olympus Cyf Type V2, Visera Cysto-Nephro Videoscope…Olympus Corporation of the Americas201425—
+2K131028Pentax Video Bronchoscopes (EB Family)Pentax Medical Company201436
+2K131902Pentax Video Upper G.I. Scopes (EG Family)Pentax Medical Company2014102
+2K131855Pentax Video Colonoscopes (EC Family)Pentax Medical Company2014136
+2K132389Cellvizio 100 Series System and Cellvizio System with Confocal Miniprobes; Uroflex B and…Daniel & Daniel Consulting201410—
+2K131422Peerscope SystemEndochoice, Inc.20132—
+2K131780Evis Exera Iii Video SystemOlympus Medical Systems Corp.201378
+2K122470Pentax Epk-I5010 Video ProcessorPentax Medical20136—
+2K123365Olympus LTF-190-10-3D, Maj-Y0154, Olympus CV-190Olympus Medical Systems Corp.201319—
+2K121582Invendo C25 Colonoscopy SystemInvendo Medical Gbmh20125—
+2K122831Video System CenterOlympus Medical Systems Corp.201219—
+2K123317Evis Exera Iii Gastrointestinal Videoscope Olympus GIXP190NOlympus Medical Systems Corporation20120—
+2K113120CHF-Y0005Olympus Medical Systems Corp.20120—
+2K111425Olympus LTF-S190-10, Olumpus Otv-S190, Olympus CLV-S190Olympus Medical Systems Corp.2012341
+2K111756V1 SystemOlympus Medical Systems Corp.201202
+2K082174Y-AdapterAsthmatx, Inc.20080—
+3K261400Ambu® aScope™ Gastro; Ambu® aScope™ Gastro LargeAmbu A/S20260—
+3K261015Solo Scope Colonoscope SystemGi View, Ltd.20260—
+3K251256PENTAX Medical Video Upper GI Scopes (EG Family) (EG Family); PENTAX Medical Video…Pentax of America, Inc.20250—
+3K251986Auxiliary Water Tube Maj-855Olympus Medical Systems Corporation20250—
+3K250862Evis Exera Iii Bronchovideoscope (Olympus BF-XP190); Evis Exera Iii Bronchovideoscope…Olympus Medical Systems Corp.20250Class I
+3K250957Disposable Biopsy Forceps (FB-211D); Disposable Biopsy Forceps (FB-221D); Disposable…Olympus Medical Systems Corporation20250—
+3K242110PENTAX Medical Video Colonoscope (EC38-i20cWL)Pentax of America, Inc.20250—
+3K241213PENTAX Medical Video Upper GI Scope (EG27-i20c); PENTAX Medical Video Colonoscope…Pentax of America, Inc.20240—
+3K240849Ambu® aScope™ 5 Cysto HD (Standard Deflection); Ambu® aScope™ 5 Cysto HD (Reverse…Ambu A/S20240—
+3K241500Endoscopic Video Image Processor (RP-IPD-V2000EF); Single-Use Video Flexible…Guangzhou Red Pine Medical Instrument Co., Ltd.20242—
+3K241371Visera S Video System Center Olympus Otv-S500 (Olympus Otv-S500)Olympus Medical Systems Corporation20240—
+3K233630Ambu® aScope™ 5 Uretero (Standard Deflection); Ambu® aScope™ 5 Uretero (Reverse…Ambu A/S20241—
+3K233886Ambu® aScope™ Duodeno 2, Ambu® aBox™ 2Ambu A/S20241—
+3K232919Ambu® aScope™ Gastro Large; Ambu® aBox™ 2Ambu A/S20241—
+3K232244Disposable Endoscope Valves SystemChangzhou Endoclean Medical Device Co., Ltd.20230—
+3K2318541788 4K Camera System with Advanced Imaging Modality; L12 LED Light Source with AIMStryker20235—
+3K230428Ambu® aScope™ 5 Broncho 2.7/1.2, Ambu® aScope™ 5 Broncho 4.2/2.2, Ambu® aBox™ 2Ambu A/S20234—
+3K231249PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Upper GI Scope…Pentax of America, Inc.202314
+3K223299Ambu® aScope™ 5 Broncho HD 5.0/2.2, Ambu® aScope™ 5 Broncho HD 5.6/2.8, Ambu® aView™ 2…Ambu A/S202361
+3K222584Evis X1 Video System Center Olympus CV-1500, Colonovideoscope Olympus CF-HQ1100DL/I…Olympus Medical Systems Corporation202321
+3K222173Saneso Lens Wash Bottle Assembly (SAN-LWB-A)Saneso, Inc.20230—
+3K221683CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-V2), CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-V2R)…Olympus Medical Systems Corporation202315
+3K223782Ambu aScope 5 Broncho HD 5.6/2.8 Sampler Set, Ambu aScope 5 Broncho HD 5.0/2.2 Sampler SetAmbu A/S20230—
+3K221690Oes Cystonephro Fiberscope (Olympus Cyf-5), Oes Cystonephro Fiberscope (Olympus Cyf-5R)…Olympus Medical Systems Corp.202203
+3K221642SIRIUS Endoscope SystemPrecision Robotics (Hong Kong) Limited20221—
+3K221638Rhino-Laryngo Videoscope Olympus ENF-VH, Rhino-Laryngo Videoscope Olympus ENF-V3Olympus Medical Systems Corp.20220—
+3K211882HD-550 Video Endoscope SystemSonoscape Medical Corp.20221—
+3K210928PENTAX Medical Video Bronchoscope EB11-J10Pentax of America, Inc.20210—
+3K210177PENTAX Medical Video Upper GI Scopes EG17-J10Pentax of America, Inc.20210—
+3K201832Endoeye Flex Deflectable Videoscope Olympus LTF-S190-5Olympus Medical Systems Corp.202101
+3K210485PENTAX Medical Video Upper GI Scopes (EG Family), PENTAX Medical Video Colonoscopes (EC…Pentax of America, Inc.202102
+3K201617TipVision Videoscope System (TipVision VideoScope 0°/30°; EleVision HD 2 Camera Control…Schoelly Fiberoptic GmbH20210—
+3K200678PENTAX Medical Video Bronchoscope EB-J10 SeriesPentax of America, Inc.20200—
+3K192793Evis Exera III Colonovideoscope Olympus PCF-H190TL, Evis Exera III Colonovideoscope…Olympus Medical Systems Corp.202003
+3K200397Single Use Biopsy Forceps FB-456DOlympus Medical Systems Corp.20200—
+3K193026Visera Elite II Video System Center, Visera Elite II Endoeye 3DOlympus Medical Systems Corp.20205—
+3K192164Single Use Guide Sheath Kit K-401, K-402, & Single Use Guiding Device CC-220DROlympus Medical Systems Corp.20201—
+3K190669EndoticsEra Endoscopy S.R.L.20200—
+3K190805PENTAX Medical Video Processor EPK-i5500c, PENTAX Medical Video Upper GI Scope…Pentax of America, Inc.20191—
+3K193202EXALT Model D Single-Use Duodenoscope, EXALT ControllerBoston Scientific Corporation201946
+3K190799PENTAX Medical Video Upper GI Scopes (EG Family)Pentax of America, Inc.20190—
+3K191282PENTAX Medical EPK-i7010 and PENTAX EPK-i5010 Video Processors with GI FamilyPentax of America, Inc.201901
+3K1836753D Visualization SystemScivita Medical Technology Co., Ltd.20190—
+3K183419EVIS EXERA III Bronchovideoscope Olympus BF-XT190Olympus Medical Systems Corp.20192Class I
+3K190449Visera Elite II Video System Center, Visera Elite II HD 3CMOS Autoclavable Camera Head…Olympus Medical Systems Corp.20195—
+3K183691PENTAX Medical ENT Video Imaging SystemPentax of America, Inc.20192—
+3K182723Flexible HD Cysto-Urethroscope SystemKARL STORZ Endoscopy-America, Inc.20193—
+3K181084PENTAX Video Colonoscopes (EC Family)Pentax of America, Inc.201932