510(k) Report

Devices descending from K013591

176 later devices reach Xenf-TP Rhino-Laryngofiberscope, Its Acessories and Ancillary Equipment through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K201200Visera Elite II Video System CenterOlympus Medical Systems Corp.20204—
+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—
+5K190805PENTAX Medical Video Processor EPK-i5500c, PENTAX Medical Video Upper GI Scope…Pentax of America, Inc.20191—
+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—
+5K183419EVIS EXERA III Bronchovideoscope Olympus BF-XT190Olympus Medical Systems Corp.20192Class I
+5K181084PENTAX Video Colonoscopes (EC Family)Pentax of America, Inc.201932
+5K182846PENTAX Medical EPK-3000 Video Imaging SystemPentax of America, Inc.20192—
+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—
+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—
+5K150221EPX-4440HD and EPX-4400HD with FICEFujifilm Medical System U.S.A., Inc.20150—
+5K131780Evis Exera Iii Video SystemOlympus Medical Systems Corp.201378
+5K122831Video System CenterOlympus Medical Systems Corp.201219—
+6K260309Ambu® aScope™ 5 Broncho 2.7/1.2; Ambu® aScope™ 5 Broncho 4.2/2.2; Ambu® aScope™ 5…Ambu A/S20260—
+6K2620794K Camera Head OLYMPUS CH-S700-08-LBOlympus Medical Systems Corp.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—
+6K251986Auxiliary Water Tube Maj-855Olympus Medical Systems Corporation20250—
+6K250939SIRIUS Endoscope System (PR-SI-1230)Precision Robotics (Hong Kong) Limited20250—
+6K244017FUJIFILM Endoscope Model EB-710P; FUJIFILM Processor EP-8000Fujifilm Corporation20250—
+6K251127PENTAX Medical Video Processor (EPK-i8020c)Pentax of America, Inc.202501
+6K243260FUJIFILM Processor EP-8000; FUJIFILM Endoscope Model EG-860RFujifilm Corporation20251—
+6K243380Visera S Video System Center Olympus Otv-S500 (Olympus Otv-S500)Olympus Medical Systems Corporation20250—
+6K242108Ambu® aScope™ 5 Uretero (Standard Deflection); Ambu® aScope™ 5 Uretero (Reverse…Ambu A/S20240—
+6K241371Visera S Video System Center Olympus Otv-S500 (Olympus Otv-S500)Olympus Medical Systems Corporation20240—
+6K232860PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Bronchoscope EB11-J10…Pentax of America, Inc.20241—
+6K232249PENTAX Medical Gas/Water Feeding Valve OE-B14Pentax of America, Inc.20230—
+6K232244Disposable Endoscope Valves SystemChangzhou Endoclean Medical Device Co., Ltd.20230—
+6K232028Q Vision Sterile Single Use Adult Flexible Gastroscope (G-100); Q Base Reusable Base…Iq Endoscopes Limited20230—
+6K222584Evis X1 Video System Center Olympus CV-1500, Colonovideoscope Olympus CF-HQ1100DL/I…Olympus Medical Systems Corporation202321
+6K222020HD-550 Video Endoscope SystemSonoscape Medical Corp.20220—
+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—
+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—
+6K202646Visera Elite II Video System CenterOlympus Medical Systems Corp.20200—
+6K192793Evis Exera III Colonovideoscope Olympus PCF-H190TL, Evis Exera III Colonovideoscope…Olympus Medical Systems Corp.202003
+6K192286FUJIFILM EP-6000 Video ProcessorFujifilm Corporation20200—
+6K192588G-EYE SystemSmart Medical Systems, Ltd.20202—
+6K192918Video Laparoscope, Video Processor, Light SourceFujifilm Corporation20206—
+6K193202EXALT Model D Single-Use Duodenoscope, EXALT ControllerBoston Scientific Corporation201946
+6K160275Fuse Endoscopic System with FuseBox ProcessorEndochoice, Inc.20160—
+7K261880FUJIFILM Processor EP-8000;Balloon Controller PB-30;Endoscopy Support Program EW10-VM01Fujifilm Corporation20260—
+7K243261FUJIFILM Endoscope Model EC-860P/M; FUJIFILM Endoscope Model EC-860P/L; FUJIFILM…Fujifilm Corporation20250—
+7K250432Colonovideoscope (CF-EZ1500DL); Colonovideoscope (CF-EZ1500DI); Gastrointestinal…Olympus Medical Systems Corporation20250—
+7K233942PENTAX Medical Video Duodenoscope (ED34-i10T2s); PENTAX Medical Video Processor…Pentax of America, Inc.20240—
+7K223759Arthrex SynergyID Endoscopic Imaging SystemArthex, Inc.20234—
+7K213606EvoEndo Single-Use Endoscopy SystemEvoEndo, Inc.20223—
+7K203717Processor VP-7000, Light Source BL-7000X, Image Processing Unit EX-0Fujifilm Corporaton20213—
+7K202469G-EYE SystemSmart Medical Systems, Ltd.20201—
+7K202130FUJIFILM Video LaparoscopeFujifilm Corporation20201—
+8K251708EvoEndo Single-Use Endoscopy SystemEvoEndo, Inc.20251—
+8K250268HyperSnap Surgical System (HSS)Hypervision Surgical20251—
+8K250900EvoEndo Single-Use Endoscopy SystemEvoEndo, Inc.20250—
+8K233225SCHOELLY Oxygen Saturation Imaging (OSI) Camera System (Camera Control Unit, Camera Head…Schoelly Fiberoptic GmbH20240—
+8K233451Arthrex Synergy Vision Endoscopic Imaging SystemArthrex, Inc.20243—
+8K220158G-EYE SystemSmart Medical Systems, Ltd.20220—
+8K212950FUJIFILM Video Laparoscope EL-R740M30Fujifilm Corporaton20210—
+9K253984Instrument Exit Point on Touch Surgery™ AideCovidien, LLC20260—
+9K260573EvoEndo Single-Use Endoscopy SystemEvoEndo, Inc.20260—
+9K241361Arthrex Synergy Vision Endoscopic Imaging SystemArthrex, Inc.20242—
+10K250728Arthrex Synergy Vision Endoscopic Imaging SystemArthrex, Inc.20251—
+11K251994Arthrex Synergy Vision Imaging SystemArthrex, Inc.20250—