510(k) Report

Devices descending from K031648

159 later devices reach Visera Rhino-Laryngovideoscope Olympus Enf Type V through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K061313Evis Exera 180 SystemOlympus Medical Systems Corporation2006158Class I
+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—
+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—
+2K162151PENTAX Medical ENT Video Imaging SystemPentax of America, Inc.20176—
+2K131028Pentax Video Bronchoscopes (EB Family)Pentax Medical Company201436
+2K121959Evis Exera Iii Video SystemOlympus Medical Systems Corp.201314Class I
+2K111425Olympus LTF-S190-10, Olumpus Otv-S190, Olympus CLV-S190Olympus Medical Systems Corp.2012341
+2K100584Evis Exeraii 180 SystemOlympus Medical Systems Corporation20101329
+2K082174Y-AdapterAsthmatx, Inc.20080—
+3K260503Triton 1 SystemNeptune Medical, Inc.20260—
+3K252341Evis Exera Iii Bronchovideoscope (Olympus BF-Q190); Evis Exera Iii Bronchovideoscope…Olympus Medical Systems Corp.20260—
+3K232043Endoscopic Video Image Processor (RP-IPD-V2000A, RP-IPD-V2000B, RP-IPD-V2000C…Guangzhou Red Pine Medical Instrument Co., Ltd.20240—
+3K2318541788 4K Camera System with Advanced Imaging Modality; L12 LED Light Source with AIMStryker20235—
+3K230332Ambu® aScope™ Colon; Ambu® aBox™ 2Ambu A/S20236—
+3K230588Aer-O-Scope Colonoscope SystemGi View, Ltd.20231—
+3K230428Ambu® aScope™ 5 Broncho 2.7/1.2, Ambu® aScope™ 5 Broncho 4.2/2.2, Ambu® aBox™ 2Ambu A/S20234—
+3K222861EVIS XI Video System Center Olympus CV-1500, Bronchovideoscope Olympus BF-H1100…Olympus Medical Systems Corporation20231—
+3K223299Ambu® aScope™ 5 Broncho HD 5.0/2.2, Ambu® aScope™ 5 Broncho HD 5.6/2.8, Ambu® aView™ 2…Ambu A/S202361
+3K223782Ambu aScope 5 Broncho HD 5.6/2.8 Sampler Set, Ambu aScope 5 Broncho HD 5.0/2.2 Sampler SetAmbu A/S20230—
+3K221638Rhino-Laryngo Videoscope Olympus ENF-VH, Rhino-Laryngo Videoscope Olympus ENF-V3Olympus Medical Systems Corp.20220—
+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—
+3K210928PENTAX Medical Video Bronchoscope EB11-J10Pentax of America, Inc.20210—
+3K201617TipVision Videoscope System (TipVision VideoScope 0°/30°; EleVision HD 2 Camera Control…Schoelly Fiberoptic GmbH20210—
+3K192704Endofresh Digestive Endoscopy SystemHuizhou Xzing Technology Co., Ltd.20200—
+3K200678PENTAX Medical Video Bronchoscope EB-J10 SeriesPentax of America, Inc.20200—
+3K201098Ambu Duodeno SystemAmbu Innovation GmbH20202—
+3K193026Visera Elite II Video System Center, Visera Elite II Endoeye 3DOlympus Medical Systems Corp.20205—
+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—
+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
+3K172156PENTAX Medical EPK-3000 Video Imaging SystemPentax Medical20183—
+3K173554PENTAX Medical Video Bronchoscopes, PENTAX Medical Video Naso-Pharyngo-Laryngoscope, and…Pentax of America, Inc.20180—
+3K173085invendoscopy E210 SystemInvendo Medical GmbH20180—
+3K161355invendoscopy E200 SystemInvendo Medical GmbH20161—
+3K143727PENTAX Medical EKP-i5010 Video Processor with EB FamilyPentax of America, Inc.20153—
+3K151011Visera 4K Uhd SystemOlympus Medical Systems Corp.20153—
+3K140149Epx-4440HD Digital Video ProcessorFujifilm Medical Systems U.S.A, Inc.201416—
+3K131902Pentax Video Upper G.I. Scopes (EG Family)Pentax Medical Company2014102
+3K131855Pentax Video Colonoscopes (EC Family)Pentax Medical Company2014136
+3K131422Peerscope SystemEndochoice, Inc.20132—
+3K122470Pentax Epk-I5010 Video ProcessorPentax Medical20136—
+3K123365Olympus LTF-190-10-3D, Maj-Y0154, Olympus CV-190Olympus Medical Systems Corp.201319—
+3K123317Evis Exera Iii Gastrointestinal Videoscope Olympus GIXP190NOlympus Medical Systems Corporation20120—
+3K113120CHF-Y0005Olympus Medical Systems Corp.20120—
+3K111756V1 SystemOlympus Medical Systems Corp.201202
+3K112680Evis Exera Iii Video SystemOlympus Medical Systems Corporation2012576
+4K261400Ambu® aScope™ Gastro; Ambu® aScope™ Gastro LargeAmbu A/S20260—
+4K261015Solo Scope Colonoscope SystemGi View, Ltd.20260—
+4K261260HD Camera Head OLYMPUS CH-S200-08-LBOlympus Medical Systems Corporation20260—
+4K261037780 nm SPY Portable Handheld Imaging (SPY-PHI) SystemStryker Endoscopy20260—
+4K260695da Vinci Firefly Imaging SystemIntuitive Surgical20260—
+4K253184Video Rhinolaryngoscope System (Disposable Video Rhinolaryngoscope SP11A Endoscopic…Zhuhai Wesee Meditech Co., Ltd.20260—
+4K260108L12 LED Light Source with AIMStryker Endoscopy20260—
+4K251256PENTAX Medical Video Upper GI Scopes (EG Family) (EG Family); PENTAX Medical Video…Pentax of America, Inc.20250—
+4K2505514K Endoscopic Camera System (SV-800, SV-800I, SV-800R, SV-800N)Shenzhen Sophway Technology Co., Ltd.20250—
+4K250862Evis Exera Iii Bronchovideoscope (Olympus BF-XP190); Evis Exera Iii Bronchovideoscope…Olympus Medical Systems Corp.20250Class I
+4K250957Disposable Biopsy Forceps (FB-211D); Disposable Biopsy Forceps (FB-221D); Disposable…Olympus Medical Systems Corporation20250—
+4K242067Visera Elite Iii Video System Center Olympus Otv-S700; Visera Elite Iii Led Light Source…Olympus Corporations of the Americas20252—
+4K242416Single-use Flexible Bronchoscope: BC-E1C10, BC-E1C11, BC-E1C12, BC-E1E10, BC-E1E11…Hunan Vathin Medical Instrument Co., Ltd.20250—
+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—
+4K241612Video Bronchoscope System; Single-use Flexible Bronchoscope (BC-S1E00-L, BC-S1H00-L…Hunan Vathin Medical Instrument Co., Ltd.20240—
+4K240849Ambu® aScope™ 5 Cysto HD (Standard Deflection); Ambu® aScope™ 5 Cysto HD (Reverse…Ambu A/S20240—
+4K233630Ambu® aScope™ 5 Uretero (Standard Deflection); Ambu® aScope™ 5 Uretero (Reverse…Ambu A/S20241—
+4K232997EVIS Exera III Gastrointestinal Videoscope GIF-1TH190Olympus Medical Systems Corporation202412
+4K233886Ambu® aScope™ Duodeno 2, Ambu® aBox™ 2Ambu A/S20241—
+4K232919Ambu® aScope™ Gastro Large; Ambu® aBox™ 2Ambu A/S20241—
+4K2333271788 4K Camera System with Advanced Imaging ModalityStryker Endoscopy20241—
+4K233671Ambu® aScope™ 5 Broncho 4.2/2.2; Ambu® aScope™ 5 Broncho 2.7/1.2; Ambu® aView™ 2 AdvanceAmbu A/S20242—
+4K232582Ambu® aScope™ 5 Broncho 4.2/2.2 Sampler SetAmbu A/S202311
+4K231249PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Upper GI Scope…Pentax of America, Inc.202314
+4K222173Saneso Lens Wash Bottle Assembly (SAN-LWB-A)Saneso, Inc.20230—
+4K221642SIRIUS Endoscope SystemPrecision Robotics (Hong Kong) Limited20221—
+4K220465PENTAX Medical EPK-3000 Imaging System with Camera Head PVK-J10, PENTAX Medical ENT…Pentax of America, Inc.20221—
+4K211882HD-550 Video Endoscope SystemSonoscape Medical Corp.20221—
+4K210177PENTAX Medical Video Upper GI Scopes EG17-J10Pentax of America, Inc.20210—
+4K201832Endoeye Flex Deflectable Videoscope Olympus LTF-S190-5Olympus Medical Systems Corp.202101
+4K210485PENTAX Medical Video Upper GI Scopes (EG Family), PENTAX Medical Video Colonoscopes (EC…Pentax of America, Inc.202102
+4K2002164K UHD Camera SystemScivita Medical Technology Co., Ltd.20200—
+4K201200Visera Elite II Video System CenterOlympus Medical Systems Corp.20204—
+4K200542Visera Elite II Xenon Light Source, Telescope IR/Telescope Ultra, Visera Elite II Video…Olympus Medical Systems Corp.20200—
+4K200397Single Use Biopsy Forceps FB-456DOlympus Medical Systems Corp.20200—
+4K192164Single Use Guide Sheath Kit K-401, K-402, & Single Use Guiding Device CC-220DROlympus Medical Systems Corp.20201—
+4K190805PENTAX Medical Video Processor EPK-i5500c, PENTAX Medical Video Upper GI Scope…Pentax of America, Inc.20191—
+4K190799PENTAX Medical Video Upper GI Scopes (EG Family)Pentax of America, Inc.20190—
+4K191282PENTAX Medical EPK-i7010 and PENTAX EPK-i5010 Video Processors with GI FamilyPentax of America, Inc.201901
+4K1836753D Visualization SystemScivita Medical Technology Co., Ltd.20190—
+4K183419EVIS EXERA III Bronchovideoscope Olympus BF-XT190Olympus Medical Systems Corp.20192Class I
+4K181084PENTAX Video Colonoscopes (EC Family)Pentax of America, Inc.201932
+4K182846PENTAX Medical EPK-3000 Video Imaging SystemPentax of America, Inc.20192—
+4K180285PENTAX Medical Video Colonoscope EC34-i10T SeriesPentax Medical of America, Inc.20180—
+4K180292PENTAX Video Upper G.I. Scope EG34-i10Pentax Medical of America, Inc.20180—
+4K173679PENTAX Medical EPK-i7010 Video Processor with EB Family of ScopesPentax of America, Inc.20182—
+4K180414EPX-4440FN Digital Video Processor with Light SourceFujifilm New Development U.S.A., Inc.20180—
+4K172796Flex Robotic System and Flex Transabdominal DriveMedrobotics Corporation20180—
+4K1728174K Camera Head Olympus CH-S400-XZ-EB, 4K Autoclavable Camera Head Olympus CH-S400-XZ-EAOlympus Medical Systems Corp.20170—