510(k) Report

Devices descending from K002749

60 later devices reach Endoscope Contour Detection Device, Model 3DX45 and Colonoscope, Model… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K134026Endoscope Position Marking Probe,Endoscope Position Detecting UnitOlympus Medical Systems Corp.20140—
+1K112680Evis Exera Iii Video SystemOlympus Medical Systems Corporation2012576
+1K103312UPD-Y0003Olympus Medical Systems Corporation20111—
+2K232997EVIS Exera III Gastrointestinal Videoscope GIF-1TH190Olympus Medical Systems Corporation202412
+2K131780Evis Exera Iii Video SystemOlympus Medical Systems Corp.201378
+2K122470Pentax Epk-I5010 Video ProcessorPentax Medical20136—
+2K123365Olympus LTF-190-10-3D, Maj-Y0154, Olympus CV-190Olympus Medical Systems Corp.201319—
+2K122831Video System CenterOlympus Medical Systems Corp.201219—
+3K251986Auxiliary Water Tube Maj-855Olympus Medical Systems Corporation20250—
+3K241371Visera S Video System Center Olympus Otv-S500 (Olympus Otv-S500)Olympus Medical Systems Corporation20240—
+3K232244Disposable Endoscope Valves SystemChangzhou Endoclean Medical Device Co., Ltd.20230—
+3K222861EVIS XI Video System Center Olympus CV-1500, Bronchovideoscope Olympus BF-H1100…Olympus Medical Systems Corporation20231—
+3K222584Evis X1 Video System Center Olympus CV-1500, Colonovideoscope Olympus CF-HQ1100DL/I…Olympus Medical Systems Corporation202321
+3K221642SIRIUS Endoscope SystemPrecision Robotics (Hong Kong) Limited20221—
+3K201832Endoeye Flex Deflectable Videoscope Olympus LTF-S190-5Olympus Medical Systems Corp.202101
+3K192793Evis Exera III Colonovideoscope Olympus PCF-H190TL, Evis Exera III Colonovideoscope…Olympus Medical Systems Corp.202003
+3K193026Visera Elite II Video System Center, Visera Elite II Endoeye 3DOlympus Medical Systems Corp.20205—
+3K190805PENTAX Medical Video Processor EPK-i5500c, PENTAX Medical Video Upper GI Scope…Pentax of America, Inc.20191—
+3K193202EXALT Model D Single-Use Duodenoscope, EXALT ControllerBoston Scientific Corporation201946
+3K191282PENTAX Medical EPK-i7010 and PENTAX EPK-i5010 Video Processors with GI FamilyPentax of America, Inc.201901
+3K1836753D Visualization SystemScivita Medical Technology Co., Ltd.20190—
+3K172796Flex Robotic System and Flex Transabdominal DriveMedrobotics Corporation20180—
+3K163675Processor VP-7000, Light Source BL-7000Fujifilm Medical System U.S.A., Inc.201712—
+3K150618PENTAX Medical EPK-i7010 Video Processor with GI FamilyPentax of America, Inc.20153—
+3K150525SPIES 3D Tip Cam, Image 1 SPIES CCU Image Connect, Image 1 SPIES CCU D-3 LinkKARL STORZ Endoscopy-America, Inc.20157—
+4K250939SIRIUS Endoscope System (PR-SI-1230)Precision Robotics (Hong Kong) Limited20250—
+4K250862Evis Exera Iii Bronchovideoscope (Olympus BF-XP190); Evis Exera Iii Bronchovideoscope…Olympus Medical Systems Corp.20250Class I
+4K244017FUJIFILM Endoscope Model EB-710P; FUJIFILM Processor EP-8000Fujifilm Corporation20250—
+4K243261FUJIFILM Endoscope Model EC-860P/M; FUJIFILM Endoscope Model EC-860P/L; FUJIFILM…Fujifilm Corporation20250—
+4K250432Colonovideoscope (CF-EZ1500DL); Colonovideoscope (CF-EZ1500DI); Gastrointestinal…Olympus Medical Systems Corporation20250—
+4K243260FUJIFILM Processor EP-8000; FUJIFILM Endoscope Model EG-860RFujifilm Corporation20251—
+4K232249PENTAX Medical Gas/Water Feeding Valve OE-B14Pentax of America, Inc.20230—
+4K232028Q Vision Sterile Single Use Adult Flexible Gastroscope (G-100); Q Base Reusable Base…Iq Endoscopes Limited20230—
+4K231249PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Upper GI Scope…Pentax of America, Inc.202314
+4K213606EvoEndo Single-Use Endoscopy SystemEvoEndo, Inc.20223—
+4K210116Video Endoscopy System, 3D Video Endoscopy SystemSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.20210—
+4K201526TIPCAM1 Rubina Video Endoscope SystemKarl Storz Endoscopy America20205—
+4K201200Visera Elite II Video System CenterOlympus Medical Systems Corp.20204—
+4K192286FUJIFILM EP-6000 Video ProcessorFujifilm Corporation20200—
+4K192918Video Laparoscope, Video Processor, Light SourceFujifilm Corporation20206—
+5K261880FUJIFILM Processor EP-8000;Balloon Controller PB-30;Endoscopy Support Program EW10-VM01Fujifilm Corporation20260—
+5K251708EvoEndo Single-Use Endoscopy SystemEvoEndo, Inc.20251—
+5K250900EvoEndo Single-Use Endoscopy SystemEvoEndo, Inc.20250—
+5K251127PENTAX Medical Video Processor (EPK-i8020c)Pentax of America, Inc.202501
+5K242067Visera Elite Iii Video System Center Olympus Otv-S700; Visera Elite Iii Led Light Source…Olympus Corporations of the Americas20252—
+5K223759Arthrex SynergyID Endoscopic Imaging SystemArthex, Inc.20234—
+5K203717Processor VP-7000, Light Source BL-7000X, Image Processing Unit EX-0Fujifilm Corporaton20213—
+5K202646Visera Elite II Video System CenterOlympus Medical Systems Corp.20200—
+5K202130FUJIFILM Video LaparoscopeFujifilm Corporation20201—
+6K2620794K Camera Head OLYMPUS CH-S700-08-LBOlympus Medical Systems Corp.20260—
+6K260573EvoEndo Single-Use Endoscopy SystemEvoEndo, Inc.20260—
+6K251336VISERA ELITE III Video System Center Olympus OTV-S700 (OTV-S700); VISERA ELITE III Light…Olympus Medical Systems Corp.20250—
+6K250268HyperSnap Surgical System (HSS)Hypervision Surgical20251—
+6K233225SCHOELLY Oxygen Saturation Imaging (OSI) Camera System (Camera Control Unit, Camera Head…Schoelly Fiberoptic GmbH20240—
+6K233451Arthrex Synergy Vision Endoscopic Imaging SystemArthrex, Inc.20243—
+6K212950FUJIFILM Video Laparoscope EL-R740M30Fujifilm Corporaton20210—
+7K253984Instrument Exit Point on Touch Surgery™ AideCovidien, LLC20260—
+7K241361Arthrex Synergy Vision Endoscopic Imaging SystemArthrex, Inc.20242—
+8K250728Arthrex Synergy Vision Endoscopic Imaging SystemArthrex, Inc.20251—
+9K251994Arthrex Synergy Vision Imaging SystemArthrex, Inc.20250—