510(k) Report

Devices descending from K011151

218 later devices reach Evis Exera Gastrointestinal Videoscope Gif-Q160Z through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K112680Evis Exera Iii Video SystemOlympus Medical Systems Corporation2012576
+1K053382Laparo-Thoraco Videoscope XLTF-VawOlympus Medical Systems Corporation20068—
+1K051645Evis Exera 160A SystemOlympus Medical Systems Corporation20052083
+2K232997EVIS Exera III Gastrointestinal Videoscope GIF-1TH190Olympus Medical Systems Corporation202412
+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—
+2K121959Evis Exera Iii Video SystemOlympus Medical Systems Corp.201314Class I
+2K122831Video System CenterOlympus Medical Systems Corp.201219—
+2K100624Invendo C20 Colonoscopy SystemInvendo Medical Gbmh20126—
+2K100533Vista Endoscope,89 CM, 56CM , Scout Blunt-Tipped Guide- 106 CM, 86 CM, 53 CM, Models…Vibrynt, Inc.20111—
+2K101053Olympus CF Type Y0023-L, Y0023IOlympus Medical Systems Corporation20100—
+2K100584Evis Exeraii 180 SystemOlympus Medical Systems Corporation20101329
+2K091962Polyscope Flexible Endoscopy Catheter; 10,000 Pixel Fiber Optic; Xenon Light Source…Lumenis, Inc.200911—
+2K081173Endoscopic CO2 Regulation Unit UcrOlympus Medical Systems Corporation20084—
+2K082451Stryker VideoscopeStryker Endoscopy20080—
+2K072957Evis Exera II 180 SystemOlympus Medical Systems Corporation2008171
+2K062049Evis Exera II 180 SystemOlympus Medical Systems Corporation2006158—
+2K061313Evis Exera 180 SystemOlympus Medical Systems Corporation2006158Class I
+3K260503Triton 1 SystemNeptune Medical, Inc.20260—
+3K252341Evis Exera Iii Bronchovideoscope (Olympus BF-Q190); Evis Exera Iii Bronchovideoscope…Olympus Medical Systems Corp.20260—
+3K251861FUJIFILM Endoscope Model ED-S100TP; FUJIFILM Endoscope Model ED-S100XP; FUJIFILM…Fujifilm Corporation20260—
+3K250550FUJIFILM Endoscope Model EG-S100XT and VS-1000 Display UnitFujifilm Corporation20260—
+3K251986Auxiliary Water Tube Maj-855Olympus Medical Systems Corporation20250—
+3K241371Visera S Video System Center Olympus Otv-S500 (Olympus Otv-S500)Olympus Medical Systems Corporation20240—
+3K232043Endoscopic Video Image Processor (RP-IPD-V2000A, RP-IPD-V2000B, RP-IPD-V2000C…Guangzhou Red Pine Medical Instrument Co., Ltd.20240—
+3K232244Disposable Endoscope Valves SystemChangzhou Endoclean Medical Device Co., Ltd.20230—
+3K230332Ambu® aScope™ Colon; Ambu® aBox™ 2Ambu A/S20236—
+3K230588Aer-O-Scope Colonoscope SystemGi View, Ltd.20231—
+3K222861EVIS XI Video System Center Olympus CV-1500, Bronchovideoscope Olympus BF-H1100…Olympus Medical Systems Corporation20231—
+3K230280ANDORATE® Suction Valve and ANDORATE® Biopsy ValveGa Health Company Limited20230—
+3K222584Evis X1 Video System Center Olympus CV-1500, Colonovideoscope Olympus CF-HQ1100DL/I…Olympus Medical Systems Corporation202321
+3K221642SIRIUS Endoscope SystemPrecision Robotics (Hong Kong) Limited20221—
+3K220606Ambu aScope 5 Broncho HD 5.6/2.8, Ambu aScope 5 Broncho HD 5.0/2.2, Ambu aBox 2Ambu A/S202210—
+3K210052Saneso Colonoscope 360-A (Model: with/without Select Band Imaging (SBI) and with/without…Saneso, Inc.20221—
+3K212382Ambu® aScope™ Gastro, Ambu® aBox™2Ambu A/S20222—
+3K201832Endoeye Flex Deflectable Videoscope Olympus LTF-S190-5Olympus Medical Systems Corp.202101
+3K192704Endofresh Digestive Endoscopy SystemHuizhou Xzing Technology Co., Ltd.20200—
+3K201098Ambu Duodeno SystemAmbu Innovation GmbH20202—
+3K192793Evis Exera III Colonovideoscope Olympus PCF-H190TL, Evis Exera III Colonovideoscope…Olympus Medical Systems Corp.202003
+3K193026Visera Elite II Video System Center, Visera Elite II Endoeye 3DOlympus Medical Systems Corp.20205—
+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
+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—
+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—
+3K183264Flex-THOR scopeKARL STORZ Endoscopy-America, Inc.20190—
+3K173921HD-500 Video Endoscope SystemSonoscape Medical Corp.20182—
+3K172726EVIS EXERA III BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-MP190F, Single Use Biopsy Forceps FB-433DOlympus Medical Systems Corp.201872
+3K172246Olympus Urf-V2/V2ROlympus Medical Systems Corp.201823
+3K172796Flex Robotic System and Flex Transabdominal DriveMedrobotics Corporation20180—
+3K173085invendoscopy E210 SystemInvendo Medical GmbH20180—
+3K163675Processor VP-7000, Light Source BL-7000Fujifilm Medical System U.S.A., Inc.201712—
+3K162151PENTAX Medical ENT Video Imaging SystemPentax of America, Inc.20176—
+3K161355invendoscopy E200 SystemInvendo Medical GmbH20161—
+3K161791Aer-O-Scope Colonoscope SystemGi View, Ltd.20160—
+3K150618PENTAX Medical EPK-i7010 Video Processor with GI FamilyPentax of America, Inc.20153—
+3K150525SPIES 3D Tip Cam, Image 1 SPIES CCU Image Connect, Image 1 SPIES CCU D-3 LinkKARL STORZ Endoscopy-America, Inc.20157—
+3K143727PENTAX Medical EKP-i5010 Video Processor with EB FamilyPentax of America, Inc.20153—
+3K141286Aer-O-Scope Colonoscope SystemGi View, Ltd.20142—
+3K140149Epx-4440HD Digital Video ProcessorFujifilm Medical Systems U.S.A, Inc.201416—
+3K133538Visera Cysto-Nephro Videoscope Olympus Cyf Type V2, Visera Cysto-Nephro Videoscope…Olympus Corporation of the Americas201425—
+3K131028Pentax Video Bronchoscopes (EB Family)Pentax Medical Company201436
+3K131902Pentax Video Upper G.I. Scopes (EG Family)Pentax Medical Company2014102
+3K131855Pentax Video Colonoscopes (EC Family)Pentax Medical Company2014136
+3K132389Cellvizio 100 Series System and Cellvizio System with Confocal Miniprobes; Uroflex B and…Daniel & Daniel Consulting201410—
+3K131422Peerscope SystemEndochoice, Inc.20132—
+3K121582Invendo C25 Colonoscopy SystemInvendo Medical Gbmh20125—
+3K123317Evis Exera Iii Gastrointestinal Videoscope Olympus GIXP190NOlympus Medical Systems Corporation20120—
+3K113120CHF-Y0005Olympus Medical Systems Corp.20120—
+3K111425Olympus LTF-S190-10, Olumpus Otv-S190, Olympus CLV-S190Olympus Medical Systems Corp.2012341
+3K111756V1 SystemOlympus Medical Systems Corp.201202
+3K111648Bracco Diagnostics, Inc. CO2MPACT Endodcopic InsufflatorBracco Diagnostic, Inc.201131
+3K082174Y-AdapterAsthmatx, Inc.20080—
+4K261400Ambu® aScope™ Gastro; Ambu® aScope™ Gastro LargeAmbu A/S20260—
+4K261015Solo Scope Colonoscope SystemGi View, Ltd.20260—
+4K251256PENTAX Medical Video Upper GI Scopes (EG Family) (EG Family); PENTAX Medical Video…Pentax of America, Inc.20250—
+4K250939SIRIUS Endoscope System (PR-SI-1230)Precision Robotics (Hong Kong) Limited20250—
+4K250862Evis Exera Iii Bronchovideoscope (Olympus BF-XP190); Evis Exera Iii Bronchovideoscope…Olympus Medical Systems Corp.20250Class I
+4K244017FUJIFILM Endoscope Model EB-710P; FUJIFILM Processor EP-8000Fujifilm Corporation20250—
+4K250957Disposable Biopsy Forceps (FB-211D); Disposable Biopsy Forceps (FB-221D); Disposable…Olympus Medical Systems Corporation20250—
+4K243261FUJIFILM Endoscope Model EC-860P/M; FUJIFILM Endoscope Model EC-860P/L; FUJIFILM…Fujifilm Corporation20250—
+4K250432Colonovideoscope (CF-EZ1500DL); Colonovideoscope (CF-EZ1500DI); Gastrointestinal…Olympus Medical Systems Corporation20250—
+4K243260FUJIFILM Processor EP-8000; FUJIFILM Endoscope Model EG-860RFujifilm Corporation20251—
+4K242110PENTAX Medical Video Colonoscope (EC38-i20cWL)Pentax of America, Inc.20250—
+4K241213PENTAX Medical Video Upper GI Scope (EG27-i20c); PENTAX Medical Video Colonoscope…Pentax of America, Inc.20240—
+4K240849Ambu® aScope™ 5 Cysto HD (Standard Deflection); Ambu® aScope™ 5 Cysto HD (Reverse…Ambu A/S20240—
+4K241500Endoscopic Video Image Processor (RP-IPD-V2000EF); Single-Use Video Flexible…Guangzhou Red Pine Medical Instrument Co., Ltd.20242—
+4K233630Ambu® aScope™ 5 Uretero (Standard Deflection); Ambu® aScope™ 5 Uretero (Reverse…Ambu A/S20241—
+4K233886Ambu® aScope™ Duodeno 2, Ambu® aBox™ 2Ambu A/S20241—
+4K232919Ambu® aScope™ Gastro Large; Ambu® aBox™ 2Ambu A/S20241—
+4K232249PENTAX Medical Gas/Water Feeding Valve OE-B14Pentax of America, Inc.20230—
+4K232028Q Vision Sterile Single Use Adult Flexible Gastroscope (G-100); Q Base Reusable Base…Iq Endoscopes Limited20230—
+4K2318541788 4K Camera System with Advanced Imaging Modality; L12 LED Light Source with AIMStryker20235—
+4K230428Ambu® aScope™ 5 Broncho 2.7/1.2, Ambu® aScope™ 5 Broncho 4.2/2.2, Ambu® aBox™ 2Ambu A/S20234—
+4K231249PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Upper GI Scope…Pentax of America, Inc.202314
+4K223299Ambu® aScope™ 5 Broncho HD 5.0/2.2, Ambu® aScope™ 5 Broncho HD 5.6/2.8, Ambu® aView™ 2…Ambu A/S202361
+4K222173Saneso Lens Wash Bottle Assembly (SAN-LWB-A)Saneso, Inc.20230—
+4K221683CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-V2), CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-V2R)…Olympus Medical Systems Corporation202315