510(k) Report

Devices descending from K981543

431 later devices reach Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories and… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K201617TipVision Videoscope System (TipVision VideoScope 0°/30°; EleVision HD 2 Camera Control…Schoelly Fiberoptic GmbH20210—
+4K202180Broncoflex Agile; Product Reference: 20030001 , Broncoflex Vortex; Product Reference…Axess Vision Technology20201—
+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—
+4K191828Vathin Video Bronchoscope SystemHunan Vathin Medical Instrument Co., Ltd.20208—
+4K192322T-Stat 2.0 Microvascular Tissue OximeterSpectros Corporation20190—
+4K183416Rhino-Laryngo Videoscope Olympus ENF-VT3Olympus Medical Systems Corp.201901
+4K190449Visera Elite II Video System Center, Visera Elite II HD 3CMOS Autoclavable Camera Head…Olympus Medical Systems Corp.20195—
+4K182723Flexible HD Cysto-Urethroscope SystemKARL STORZ Endoscopy-America, Inc.20193—
+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
+4K173085invendoscopy E210 SystemInvendo Medical GmbH20180—
+4K162151PENTAX Medical ENT Video Imaging SystemPentax of America, Inc.20176—
+4K1629163NT endoscopy system3nt Medical, Ltd.20173—
+4K161355invendoscopy E200 SystemInvendo Medical GmbH20161—
+4K143727PENTAX Medical EKP-i5010 Video Processor with EB FamilyPentax of America, Inc.20153—
+4K151011Visera 4K Uhd SystemOlympus Medical Systems Corp.20153—
+4K140149Epx-4440HD Digital Video ProcessorFujifilm Medical Systems U.S.A, Inc.201416—
+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
+4K131422Peerscope SystemEndochoice, Inc.20132—
+4K131780Evis Exera Iii Video SystemOlympus Medical Systems Corp.201378
+4K122470Pentax Epk-I5010 Video ProcessorPentax Medical20136—
+4K123365Olympus LTF-190-10-3D, Maj-Y0154, Olympus CV-190Olympus Medical Systems Corp.201319—
+4K122831Video System CenterOlympus Medical Systems Corp.201219—
+4K123317Evis Exera Iii Gastrointestinal Videoscope Olympus GIXP190NOlympus Medical Systems Corporation20120—
+4K113120CHF-Y0005Olympus Medical Systems Corp.20120—
+4K111756V1 SystemOlympus Medical Systems Corp.201202
+4K102366Finess EndoscopeEntellus Medical, Inc.20110—
+4K094030Fore-Sight Absolute Cerebral and Somatic Oximeter, MC 2000 Series, Models MC2000…Cas Medical Systems, Inc.201053—
+4K102715Regional OximeterNonin Medical, Inc.201053—
+4K090814Modification to Gyrus Acmi Invisio Icn, Models Icn-0564 and Icn-0565Gyrus Acmi, Inc.20090—
+4K082174Y-AdapterAsthmatx, Inc.20080—
+4K073407PacificaOr-Nim Medical, Ltd.20081—
+4K060269Acmi Dur-Digital Ureteroscope and Choledochoscope SystemAcmi Corporation200699—
+5K261637Single-use Flexible BronchoscopeHunan Vathin Medical Instrument Co., Ltd.20260—
+5K261400Ambu® aScope™ Gastro; Ambu® aScope™ Gastro LargeAmbu A/S20260—
+5K261015Solo Scope Colonoscope SystemGi View, Ltd.20260—
+5K261260HD Camera Head OLYMPUS CH-S200-08-LBOlympus Medical Systems Corporation20260—
+5K261037780 nm SPY Portable Handheld Imaging (SPY-PHI) SystemStryker Endoscopy20260—
+5K260695da Vinci Firefly Imaging SystemIntuitive Surgical20260—
+5K260108L12 LED Light Source with AIMStryker Endoscopy20260—
+5K251256PENTAX Medical Video Upper GI Scopes (EG Family) (EG Family); PENTAX Medical Video…Pentax of America, Inc.20250—
+5K2505514K Endoscopic Camera System (SV-800, SV-800I, SV-800R, SV-800N)Shenzhen Sophway Technology Co., Ltd.20250—
+5K251986Auxiliary Water Tube Maj-855Olympus Medical Systems Corporation20250—
+5K252598Flexible Cystoscope (CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US)Shanghai AnQing Medical Instrument Co., Ltd.20250—
+5K250797UV5000 HandleUroviu Corporation20250—
+5K252176Single-Use Video Flexible Cysto-Nephroscope (RP-U-C01F, RP-U-C01FS)Guangzhou Red Pine Medical Instrument Co., Ltd.20250—
+5K250862Evis Exera Iii Bronchovideoscope (Olympus BF-XP190); Evis Exera Iii Bronchovideoscope…Olympus Medical Systems Corp.20250Class I
+5K250269Ambu® aScope™ 5 Cysto HD (Standard Deflection); Ambu® aScope™ 5 Cysto HD (Reverse…Ambu A/S20250—
+5K250957Disposable Biopsy Forceps (FB-211D); Disposable Biopsy Forceps (FB-221D); Disposable…Olympus Medical Systems Corporation20250—
+5K243497Portable Video Processor (EA101), Flexible Bronchoscope BS41H-12EU, BS41H-12US…Shanghai AnQing Medical Instrument Co., Ltd.20251—
+5K243541LumiRex BronchoscopeContra Healthcare Solutions, LLC20250—
+5K242067Visera Elite Iii Video System Center Olympus Otv-S700; Visera Elite Iii Led Light Source…Olympus Corporations of the Americas20252—
+5K242010Bronchoscope System, The Single-use Bronchoscope (Single-use Bronchoscope: SP-Y-ZQGJ2.8…Shenzhen Sanping Image Technology Co., Ltd.20250—
+5K243321Endoscopic Video Image Processor (RP-IPD-V1000F)Guangzhou Red Pine Medical Instrument Co., Ltd.20250—
+5K242416Single-use Flexible Bronchoscope: BC-E1C10, BC-E1C11, BC-E1C12, BC-E1E10, BC-E1E11…Hunan Vathin Medical Instrument Co., Ltd.20250—
+5K242110PENTAX Medical Video Colonoscope (EC38-i20cWL)Pentax of America, Inc.20250—
+5K243196Uro-G HD Cystoscope (1520)Uroviu Corporation20240—
+5K241213PENTAX Medical Video Upper GI Scope (EG27-i20c); PENTAX Medical Video Colonoscope…Pentax of America, Inc.20240—
+5K241612Video Bronchoscope System; Single-use Flexible Bronchoscope (BC-S1E00-L, BC-S1H00-L…Hunan Vathin Medical Instrument Co., Ltd.20240—
+5K241371Visera S Video System Center Olympus Otv-S500 (Olympus Otv-S500)Olympus Medical Systems Corporation20240—
+5K233630Ambu® aScope™ 5 Uretero (Standard Deflection); Ambu® aScope™ 5 Uretero (Reverse…Ambu A/S20241—
+5K240283BubbleView™ Single-Use Digital Flexible Cystoscope (C50-C, C50-CR, C50-CB, C50-CBR)…MacroLux Medical Technology Co., Ltd.20240—
+5K233886Ambu® aScope™ Duodeno 2, Ambu® aBox™ 2Ambu A/S20241—
+5K232919Ambu® aScope™ Gastro Large; Ambu® aBox™ 2Ambu A/S20241—
+5K231107Bronchoscope SystemHunan Endoso Life Technology Co., Ltd.20241—
+5K231970PENTAX Medical Single Use Video Bronchoscope EB11-S01, PENTAX Medical Single Use Video…Pentax of America, Inc.20240—
+5K2333271788 4K Camera System with Advanced Imaging ModalityStryker Endoscopy20241—
+5K232244Disposable Endoscope Valves SystemChangzhou Endoclean Medical Device Co., Ltd.20230—
+5K231702WiScope® Digital Cystoscope System, WiScope® Single-Use Digital Flexible Cystoscope…OTU Medical, Inc.20230—
+5K230428Ambu® aScope™ 5 Broncho 2.7/1.2, Ambu® aScope™ 5 Broncho 4.2/2.2, Ambu® aBox™ 2Ambu A/S20234—
+5K231249PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Upper GI Scope…Pentax of America, Inc.202314
+5K223299Ambu® aScope™ 5 Broncho HD 5.0/2.2, Ambu® aScope™ 5 Broncho HD 5.6/2.8, Ambu® aView™ 2…Ambu A/S202361
+5K222584Evis X1 Video System Center Olympus CV-1500, Colonovideoscope Olympus CF-HQ1100DL/I…Olympus Medical Systems Corporation202321
+5K222173Saneso Lens Wash Bottle Assembly (SAN-LWB-A)Saneso, Inc.20230—
+5K223782Ambu aScope 5 Broncho HD 5.6/2.8 Sampler Set, Ambu aScope 5 Broncho HD 5.0/2.2 Sampler SetAmbu A/S20230—
+5K221642SIRIUS Endoscope SystemPrecision Robotics (Hong Kong) Limited20221—
+5K221638Rhino-Laryngo Videoscope Olympus ENF-VH, Rhino-Laryngo Videoscope Olympus ENF-V3Olympus Medical Systems Corp.20220—
+5K222014EXALT Model B Single-Use BronchoscopeBoston Scientific Corporation20220—
+5K211882HD-550 Video Endoscope SystemSonoscape Medical Corp.20221—
+5K212886Broncoflex Agile, Broncoflex Vortex, ScreeniAxess Vision Technology20220—
+5K210928PENTAX Medical Video Bronchoscope EB11-J10Pentax of America, Inc.20210—
+5K210177PENTAX Medical Video Upper GI Scopes EG17-J10Pentax of America, Inc.20210—
+5K201832Endoeye Flex Deflectable Videoscope Olympus LTF-S190-5Olympus Medical Systems Corp.202101
+5K210379Broncho Videoscope SystemScivita Medical Technology Co., Ltd.20213—
+5K202727Peregrine Endoscopy System3nt Medical, Ltd.20210—
+5K210579WiScope OM Endoscope System, WiScope Single-Use Digital Flexible…OTU Medical, Inc.20211—
+5K210485PENTAX Medical Video Upper GI Scopes (EG Family), PENTAX Medical Video Colonoscopes (EC…Pentax of America, Inc.202102
+5K202346SPiN Vision Video Bronchoscope SystemVeran Medical Technologies, Inc.20210—
+5K2002164K UHD Camera SystemScivita Medical Technology Co., Ltd.20200—
+5K200678PENTAX Medical Video Bronchoscope EB-J10 SeriesPentax of America, Inc.20200—
+5K201200Visera Elite II Video System CenterOlympus Medical Systems Corp.20204—
+5K192793Evis Exera III Colonovideoscope Olympus PCF-H190TL, Evis Exera III Colonovideoscope…Olympus Medical Systems Corp.202003
+5K200542Visera Elite II Xenon Light Source, Telescope IR/Telescope Ultra, Visera Elite II Video…Olympus Medical Systems Corp.20200—
+5K200397Single Use Biopsy Forceps FB-456DOlympus Medical Systems Corp.20200—
+5K192164Single Use Guide Sheath Kit K-401, K-402, & Single Use Guiding Device CC-220DROlympus Medical Systems Corp.20201—