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
+1K221631Tracheal Intubation Fiberscope OLYMPUS LF-P, VISERA Tracheal Intubation Videoscope…Olympus Medical Systems Corp.202204
+1K130845Ambu Ascope 3 5.0/2.2; Ambu Ascope 3 Slim 3.8/1.2; Ambu AviewAmbu A/S201364—
+1K082720Tracheal Intubation Fibervideoscope, Models LF-Y0004 and LF-Y0005Olympus Medical Systems Corporation200813
+1K021074Visera Cystovideoscope Olympus Cyf Type V/VAOlympus America, Inc.2002268—
+1K013591Xenf-TP Rhino-Laryngofiberscope, Its Acessories and Ancillary EquipmentOlympus Optical Co., Ltd.2001176—
+1K011869Xenf-DP Rhino-Laryngofiberscope, Its Accessories and Ancillary EquipmentThe Olympus Optical Co.200182—
+1K002231LF-DP Gastrointestinal and Sigmoid Fiberscope, Accessories and Ancillary EquipmentOlympus Optical Co., Ltd.200183—
+2K252050Disposable Biopsy Forceps FB-211D, FB-221D, FB-231D, FB-241DOlympus Medical Systems Corporation20260—
+2K201300Airway MobilescopeOlympus Medical Systems Corp.202102
+2K200342Single Use Grasping Forceps FG-214P, Single Use Grasping Forceps FG-220P, Single Use…Olympus Medical Systems Corp.20200—
+2K190972Ambu aScope 4 RhinoLaryngo InterventionAmbu A/S20192—
+2K183256GlideScope BFlex Single-Use Bronchoscope SystemVerathon Medical (Canada) Ulc20196—
+2K181286Ambu aScope RLS SlimAmbu A/S20186—
+2K181240Rhino-Laryngo Fiberscope Olympus ENF-GP2Olympus Medical Systems Corp.201811
+2K171500Uro-V CystoscopeUroviu Corporation20185—
+2K161656Ambu aScope 3 Regular 5.0/2.2, Ambu aScope 3 Slim 3.8/1.2, Ambu aScope 3 Large 5.8/2.8…Ambu A/S201640—
+2K160766Ambu USR, Ambu MAmbu A/S201614—
+2K152466Neo-Bronchoscope -Digital Video Bronchoscopy System (Rigid/Flexible)Prosurg, Inc.20160—
+2K070752Ksea Miniature Endoscope, Model 11565KARL STORZ Endoscopy-America, Inc.20076—
+2K062049Evis Exera II 180 SystemOlympus Medical Systems Corporation2006158—
+2K051176Flexible Video Cystoscope/Choledochoscope, Models 7308.061 and 7308.066Richard Wolf Medical Instruments Corp.20050—
+2K052452Visera Rhino-Laryngovideoscope Olympus Enf Type VTOlympus Medical Systems Corporation2005159—
+2K040684T-Stat Microvascular Tissue Oximeter, Model 303Spectros Corporation200467—
+2K032092Olympus Xcyf-TP3 Cystofiberscope/NephrofiberscopeOlympus Optical Co., Ltd.20030—
+2K030960Ecn Electronic Video CystonephroscopeAcmi Corporation2003103—
+2K021073Visera Rhinlaryngovideoscope Olympus Enf Type VOlympus America, Inc.2002160—
+3K243639Portare System (FA-001)Grumpy Innovation, Inc.20250—
+3K230536Single-use Flexible Rhinolaryngoscope; Digital Video MonitorHunan Vathin Medical Instrument Co., Ltd.20230—
+3K221660Rhino-Laryngofiberscope Olympus Enf Type-XPOlympus Medical Systems Corp.202201
+3K221581Single-Use Flexible RhinolaryngoscopeHunan Vathin Medical Instrument Co., Ltd.20220—
+3K211947GlideScope BFlex 2.8 Single-Use BronchoscopeVerathon Medical (Canada) Ulc20213—
+3K202921Uro-G CystoscopeUroviu Corporation20213—
+3K193095Ambu aScope 4 CystoAmbu A/S202013—
+3K193488GlideScope BFlex 3.8 Single-Use BronchoscopeVerathon Medical (Canada) Ulc20204—
+3K191948GlideScope BFlex 5.8 Single-Use BronchoscopeVerathon Medical (Canada) Ulc20195—
+3K182876Uro-N CystoscopeUroviu Corporation20190—
+3K191080Ambu aScope 4 RhinoLaryngo SlimAmbu A/S20194—
+3K173727Ambu aScope 3 Slim 3.8/1.2 and Ambu aScope 4 Broncho Slim 3.8/1.2; Ambu aScope 3 Regular…Ambu A/S201839—
+3K133538Visera Cysto-Nephro Videoscope Olympus Cyf Type V2, Visera Cysto-Nephro Videoscope…Olympus Corporation of the Americas201425—
+3K121959Evis Exera Iii Video SystemOlympus Medical Systems Corp.201314Class I
+3K112826Noorvms-Oxy Tissue Oxygen and Temperture MonitorMoor Instruments, Ltd.20120—
+3K111425Olympus LTF-S190-10, Olumpus Otv-S190, Olympus CLV-S190Olympus Medical Systems Corp.2012341
+3K112680Evis Exera Iii Video SystemOlympus Medical Systems Corporation2012576
+3K100584Evis Exeraii 180 SystemOlympus Medical Systems Corporation20101329
+3K091452Fore-Sight, Model MC-2000 Series (MC 2000, MC2010, MC-2020,MC2030)Cas Medical Systems, Inc.200957—
+3K083892Fore-Sight, Model MC-2000 Series (MC-2000, MC-2010, MC2020, MC2030)Cas Medical Systems, Inc.200958—
+3K082569Entellus Medical Flexible Endoscope and EyepieceEntellus Medical, Inc.20085—
+3K081233T-Stat 303 Ischemia Monitoring SystemSpectros Corporation200856—
+3K073036Fore-Sight, MC-2000 SeriesCas Medical Systems, Inc.200859—
+3K061960Fore-Sight Cerebral Oximeter Monitor, Model 2040Cas Medical Systems, Inc.200659—
+3K061313Evis Exera 180 SystemOlympus Medical Systems Corporation2006158Class I
+3K051257Adult Cerebral Oximeter, Model 2040Cas Medical Systems, Inc.200563—
+3K042069Invisio Irl Digital Rigid Laparoscope SystemAcmi Corporation20040—
+3K042225Acmi Invisio Icn, Models Icn-0564 and Icn-0565Acmi Corporation2004101—
+3K031648Visera Rhino-Laryngovideoscope Olympus Enf Type VOlympus Optical Co., Ltd.2003159—
+4K260503Triton 1 SystemNeptune Medical, Inc.20260—
+4K252341Evis Exera Iii Bronchovideoscope (Olympus BF-Q190); Evis Exera Iii Bronchovideoscope…Olympus Medical Systems Corp.20260—
+4K260420LoopView® Single-Use Digital Flexible Bronchoscope (B27-C, B27-CG)MacroLux Medical Technology Co., Ltd.20260—
+4K253184Video Rhinolaryngoscope System (Disposable Video Rhinolaryngoscope SP11A Endoscopic…Zhuhai Wesee Meditech Co., Ltd.20260—
+4K251894Himaging Bronchscope SystemHimaging Technology (Shanghai) Co., Ltd.20250—
+4K251140Zenflow Spring ScopeZenflow, Inc.20250—
+4K251823UE BRONCHO Single-Use Bronchoscopes (EBS-380C); UE BRONCHO Single-Use Bronchoscopes…Zhejiang UE Medical Corp.20250—
+4K250232Vathin® Video Bronchoscope SystemHunan Vathin Medical Instrument Co., Ltd.20250—
+4K242793Insighters™ Single-use Bronchoscope/Insight Bimodel-Integral iS-B12A 4.6/2.0…Shenzhen Insighters Medical Technology Co., Ltd.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—
+4K234113MiiS Horus Bronchoscope; MiiS Horus Endoscope Display System -Tablet; MiiS Horus…Medimaging Integrated Solution, Inc (Miis)20240—
+4K232435Rhinolaryngoscope systemShenzhen HugeMed Medical Technical Development Co., Ltd.20240—
+4K233779LoopView® Single-Use Digital Flexible Bronchoscope (B38, B38-C, B50, B50-C, B58, B58-C)…MacroLux Medical Technology Co., Ltd.20240—
+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—
+4K230588Aer-O-Scope Colonoscope SystemGi View, Ltd.20231—
+4K222861EVIS XI Video System Center Olympus CV-1500, Bronchovideoscope Olympus BF-H1100…Olympus Medical Systems Corporation20231—
+4K230280ANDORATE® Suction Valve and ANDORATE® Biopsy ValveGa Health Company Limited20230—
+4K230948BFlex™ 2 Slim 3.8 Single-Use BronchoscopeVerathon Medical (Canada) Ulc20232—
+4K222910Bronchoscope SystemShenzhen HugeMed Medical Technical Development Co., Ltd.20230—
+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
+4K213235PENTAX Medical ONE Pulmo Single Use Video Bronchoscope SystemPentax of America, Inc.20221—
+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—
+4K213782Single-Use Video Bronchoscopes, Digital ControllerMicro-Tech (Nanjing) Co., Lts20220—
+4K214050ENT Nasopharyngoscope and AccessoriesMedimaging Integrated Solution, Inc (Miis)20220—
+4K220399WiScope Digital Bronchoscope System, WiScope Single-Use Digital Flexible Bronchoscope…OTU Medical, Inc.20220—
+4K220004Zsquare ENT-Flex EndoscopeZsquare, Ltd.20220—
+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—
+4K211169Bronchoscope SystemShanghai AnQing Medical Instrument Co., Ltd.20212—
+4K211030EXALT Model B Single-Use Bronchoscope (Slim), EXALT Model B Single-Use Bronchoscope…Boston Scientific Corporation20211—
+4K210883aScope 4 Broncho Regular Sampler Set 5.0/2.2, aScope 4 Broncho Large Sampler Set 5.8/2.8Ambu A/S20212—