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
+5K192305Colibri Endoscopy System3nt Medical, Ltd.20200—
+5K190805PENTAX Medical Video Processor EPK-i5500c, PENTAX Medical Video Upper GI Scope…Pentax of America, Inc.20191—
+5K193202EXALT Model D Single-Use Duodenoscope, EXALT ControllerBoston Scientific Corporation201946
+5K190799PENTAX Medical Video Upper GI Scopes (EG Family)Pentax of America, Inc.20190—
+5K191282PENTAX Medical EPK-i7010 and PENTAX EPK-i5010 Video Processors with GI FamilyPentax of America, Inc.201901
+5K1836753D Visualization SystemScivita Medical Technology Co., Ltd.20190—
+5K191357Flexible HD Cysto-Urethroscope SystemKARL STORZ Endoscopy-America, Inc.20192—
+5K183419EVIS EXERA III Bronchovideoscope Olympus BF-XT190Olympus Medical Systems Corp.20192Class I
+5K183691PENTAX Medical ENT Video Imaging SystemPentax of America, Inc.20192—
+5K190560SenSmart Model 8006CA Reusable Regional Oximetry Sensor, SenSmart Model 8006PI…Nonin Medical, Inc.20190—
+5K181084PENTAX Video Colonoscopes (EC Family)Pentax of America, Inc.201932
+5K180285PENTAX Medical Video Colonoscope EC34-i10T SeriesPentax Medical of America, Inc.20180—
+5K180292PENTAX Video Upper G.I. Scope EG34-i10Pentax Medical of America, Inc.20180—
+5K173679PENTAX Medical EPK-i7010 Video Processor with EB Family of ScopesPentax of America, Inc.20182—
+5K180414EPX-4440FN Digital Video Processor with Light SourceFujifilm New Development U.S.A., Inc.20180—
+5K172156PENTAX Medical EPK-3000 Video Imaging SystemPentax Medical20183—
+5K173554PENTAX Medical Video Bronchoscopes, PENTAX Medical Video Naso-Pharyngo-Laryngoscope, and…Pentax of America, Inc.20180—
+5K172796Flex Robotic System and Flex Transabdominal DriveMedrobotics Corporation20180—
+5K1728174K Camera Head Olympus CH-S400-XZ-EB, 4K Autoclavable Camera Head Olympus CH-S400-XZ-EAOlympus Medical Systems Corp.20170—
+5K163675Processor VP-7000, Light Source BL-7000Fujifilm Medical System U.S.A., Inc.201712—
+5K162836FUJIFILM Surgical SystemFujifilm New Development U.S.A., Inc.20178—
+5K152182Fuse Gastroscopy SystemEndochoice, Inc.20151—
+5K150618PENTAX Medical EPK-i7010 Video Processor with GI FamilyPentax of America, Inc.20153—
+5K150525SPIES 3D Tip Cam, Image 1 SPIES CCU Image Connect, Image 1 SPIES CCU D-3 LinkKARL STORZ Endoscopy-America, Inc.20157—
+5K153049LithoVue SystemBoston Scientific Corporation201524—
+5K150221EPX-4440HD and EPX-4400HD with FICEFujifilm Medical System U.S.A., Inc.20150—
+5K151305SenSmart Model 8203CA Regional Oximetry Sensor (Adult/Pediatric, >40 kg, SenSmart Model…Nonin Medical, Inc.20151—
+5K142922SpyGlass DS Direct Visualization SystemBoston Scientific Corporation201591
+5K142556Flexible Video-Uretero-Choledochoscope SystemKARL STORZ Endoscopy-America, Inc.20147—
+5K133879Fore-Sight Elite Absolute Tissue OximeterCas Medical Systems, Inc.201444—
+5K132402Sensmart Model X-100 Univeral Oximetry SystemNonin Medical, Inc.201431
+5K131369Flexible Video-Uretero-Renoscope SystemKARL STORZ Endoscopy-America, Inc.2013531
+5K123700Fore-Sight Elite Absolute Tissue OximeterCas Medical Systems, Inc.20130—
+5K113215Model 7600 Regional Oximeter System with Equanox TechnologyNonin Medical, Inc.201242—
+5K112820Fore-Sight Absolute Tissue OximeterCas Medical Systems, Inc.201247—
+5K093923Cerox Model 3210Or-Nim Medical, Ltd.20100—
+5K092278Gyrus Acmi Invisio Digital Hysteroscope, Model Idh-4Gyrus Acmi, Inc.200922—
+5K072594Gyrus Acmi Ipn-2505, Invisio Smith Percutaneous Nephroscope SystemGyrus Acmi, Inc.200723—
+6K2620794K Camera Head OLYMPUS CH-S700-08-LBOlympus Medical Systems Corp.20260—
+6K254153Single-use Video Scope; PB Digital ControllerMirco-Tech (Nanjing) Co., Ltd.20260—
+6K251861FUJIFILM Endoscope Model ED-S100TP; FUJIFILM Endoscope Model ED-S100XP; FUJIFILM…Fujifilm Corporation20260—
+6K2601851688 4K Camera System with Advanced Imaging Modality; 1788 4K Camera System with…Stryker Endoscopy20260—
+6K251336VISERA ELITE III Video System Center Olympus OTV-S700 (OTV-S700); VISERA ELITE III Light…Olympus Medical Systems Corp.20250—
+6K250939SIRIUS Endoscope System (PR-SI-1230)Precision Robotics (Hong Kong) Limited20250—
+6K251752Flexible Bronchoscope (BS27U-12EU, BS27U-12US, BS38U-20EU, BS38U-20US)Shanghai AnQing Medical Instrument Co., Ltd.20250—
+6K244017FUJIFILM Endoscope Model EB-710P; FUJIFILM Processor EP-8000Fujifilm Corporation20250—
+6K251127PENTAX Medical Video Processor (EPK-i8020c)Pentax of America, Inc.202501
+6K243261FUJIFILM Endoscope Model EC-860P/M; FUJIFILM Endoscope Model EC-860P/L; FUJIFILM…Fujifilm Corporation20250—
+6K250432Colonovideoscope (CF-EZ1500DL); Colonovideoscope (CF-EZ1500DI); Gastrointestinal…Olympus Medical Systems Corporation20250—
+6K243260FUJIFILM Processor EP-8000; FUJIFILM Endoscope Model EG-860RFujifilm Corporation20251—
+6K250210Broncho Videoscope System (Single-use Broncho Videoscope (SBV-1A-B, SBV-1A-P, SBV-1B-B…Scivita Medical Technology Co., Ltd.20250—
+6K241444Biliary Pancreaticobiliary Scope SystemShenzhen HugeMed Medical Technical Development Co., Ltd.20250—
+6K240289Full HD Endoscopic Image Processor (HDVS-S200A, HDVS-S200B, HDVS-S200C, HDVS-S200D)Scivita Medical Technology Co., Ltd.20240—
+6K242108Ambu® aScope™ 5 Uretero (Standard Deflection); Ambu® aScope™ 5 Uretero (Reverse…Ambu A/S20240—
+6K233275RenaFlex Single-use Flexible Ureteroscope (SUURF-V Standard); RenaFlex Single-use…Gyrus Acmi, Inc.20240—
+6K231497Choledochoscope SystemShenzhen HugeMed Medical Technical Development Co., Ltd.20240—
+6K232860PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Bronchoscope EB11-J10…Pentax of America, Inc.20241—
+6K233671Ambu® aScope™ 5 Broncho 4.2/2.2; Ambu® aScope™ 5 Broncho 2.7/1.2; Ambu® aView™ 2 AdvanceAmbu A/S20242—
+6K232249PENTAX Medical Gas/Water Feeding Valve OE-B14Pentax of America, Inc.20230—
+6K232028Q Vision Sterile Single Use Adult Flexible Gastroscope (G-100); Q Base Reusable Base…Iq Endoscopes Limited20230—
+6K231521Broncho Videoscope SystemScivita Medical Technology Co., Ltd.20231—
+6K232582Ambu® aScope™ 5 Broncho 4.2/2.2 Sampler SetAmbu A/S202311
+6K223097RenaNav Ureteroscope SystemCenterPoint Systems, LLC20230—
+6K221784Single-use Video Pancreaticobiliary Scope, PB Digital ControllerMicro-Tech (Nanjing) Co., Ltd.20232—
+6K221515StoneSmart Connect Console, LithoVue Elite Single Use Digital Flexible Ureteroscope…Boston Scientific Corporation20234—
+6K220465PENTAX Medical EPK-3000 Imaging System with Camera Head PVK-J10, PENTAX Medical ENT…Pentax of America, Inc.20221—
+6K222020HD-550 Video Endoscope SystemSonoscape Medical Corp.20220—
+6K213334Monarch Platform, UrologyAuris Health, Inc.202201
+6K211686Flexible Video-Choledo-Cysto-Ureteroscope SystemShanghai SeeGen Photoelectric Technology Co., Ltd.20222—
+6K213606EvoEndo Single-Use Endoscopy SystemEvoEndo, Inc.20223—
+6K211347Uretero1 Ureteroscope SystemSTERIS Corporation20213—
+6K210116Video Endoscopy System, 3D Video Endoscopy SystemSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.20210—
+6K212667Single Use Guide Sheath Kit-401, K-402Olympus Medical Systems Corp.20210—
+6K212476KARL STORZ Flexible HD Cysto-Urethroscope SystemKarl Storz Endoscopy America, Inc.202101
+6K201758EVIS EXERA III Bronchovideoscope Olympus BF-XP190, EVIS EXERA III Bronchovideoscope…Olympus Medical Systems Corp.20211Class I
+6K201526TIPCAM1 Rubina Video Endoscope SystemKarl Storz Endoscopy America20205—
+6K202957Flexible Video Cysto-Urethroscope (C-view)KARL STORZ Endoscopy-America, Inc.202012
+6K202646Visera Elite II Video System CenterOlympus Medical Systems Corp.20200—
+6K192900H500 Multi-Sensing Oximetry SystemNonin Medical, Inc.20200—
+6K200483SpyGlass Discover Digital Catheter, SpyGlass Discover Digital ControllerBoston Scientific Corporation20203—
+6K192286FUJIFILM EP-6000 Video ProcessorFujifilm Corporation20200—
+6K192588G-EYE SystemSmart Medical Systems, Ltd.20202—
+6K192918Video Laparoscope, Video Processor, Light SourceFujifilm Corporation20206—
+6K183188Flexible Sensor-Ureterorenoscopes BOA Vision EF, Flexible Sensor-Ureterorenoscopes COBRA…Richard Wolf Medical Instruments Corporation20191—
+6K182846PENTAX Medical EPK-3000 Video Imaging SystemPentax of America, Inc.20192—
+6K181439SpyGlass DS and DS II Direct Visualization SystemBoston Scientific Corporation20187—
+6K180367Ureterorenoscope SystemShanghai AnQing Medical Instrument Co., Ltd.20189—
+6K171113LiNA OperaScope with HDMI cable and on-board LCD-single unit, LiNA OperaScope with HDMI…Lina Medical Aps20184—
+6K172098Medical Video Endoscope SystemZhuhai Pusen Medical Technology Co., Ltd.201723—
+6K171076Medical Video Endoscope SystemZhuhai Pusen Medical Technology Co., Ltd.20174—
+6K160865Model 6100C Series Single-Patient Use, Disposable Pulse Oximeter Sensors (6100C Series…Nonin Medical, Inc.20161—
+6K160275Fuse Endoscopic System with FuseBox ProcessorEndochoice, Inc.20160—
+6K160526Masimo O3 Regional Oximeter SystemMasimo Corporation20165—
+6K150268CerOXOr-Nim Medical, Ltd.20150—
+6K143675FORE-SIGHT Elite Absolute Tissue OximeterCas Medical Systems, Inc.2015371
+6K141250Flexible Video-Uretero-Renoscope SystemKARL STORZ Endoscopy-America, Inc.2014112
+6K123151Endosee Model 8000 U-ScopeEndosee Corp201320—
+6K093218Femeye TwoFem Suite, LLC20100—
+7K260309Ambu® aScope™ 5 Broncho 2.7/1.2; Ambu® aScope™ 5 Broncho 4.2/2.2; Ambu® aScope™ 5…Ambu A/S20260—
+7K260516BubbleView Single-Use Digital Flexible Cystoscope (C38-CS, C38-CRS, C50-C, C50-CR…MacroLux Medical Technology Co., Ltd.20260—