510(k) Report

Devices descending from K061313

158 later devices reach Evis Exera 180 System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K162836FUJIFILM Surgical SystemFujifilm New Development U.S.A., Inc.20178—
+3K152182Fuse Gastroscopy SystemEndochoice, Inc.20151—
+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—
+3K150221EPX-4440HD and EPX-4400HD with FICEFujifilm Medical System U.S.A., Inc.20150—
+3K131780Evis Exera Iii Video SystemOlympus Medical Systems Corp.201378
+3K122831Video System CenterOlympus Medical Systems Corp.201219—
+4K260309Ambu® aScope™ 5 Broncho 2.7/1.2; Ambu® aScope™ 5 Broncho 4.2/2.2; Ambu® aScope™ 5…Ambu A/S20260—
+4K2620794K Camera Head OLYMPUS CH-S700-08-LBOlympus Medical Systems Corp.20260—
+4K251861FUJIFILM Endoscope Model ED-S100TP; FUJIFILM Endoscope Model ED-S100XP; FUJIFILM…Fujifilm Corporation20260—
+4K2601851688 4K Camera System with Advanced Imaging Modality; 1788 4K Camera System with…Stryker Endoscopy20260—
+4K251336VISERA ELITE III Video System Center Olympus OTV-S700 (OTV-S700); VISERA ELITE III Light…Olympus Medical Systems Corp.20250—
+4K251986Auxiliary Water Tube Maj-855Olympus Medical Systems Corporation20250—
+4K250939SIRIUS Endoscope System (PR-SI-1230)Precision Robotics (Hong Kong) Limited20250—
+4K244017FUJIFILM Endoscope Model EB-710P; FUJIFILM Processor EP-8000Fujifilm Corporation20250—
+4K251127PENTAX Medical Video Processor (EPK-i8020c)Pentax of America, Inc.202501
+4K243260FUJIFILM Processor EP-8000; FUJIFILM Endoscope Model EG-860RFujifilm Corporation20251—
+4K243380Visera S Video System Center Olympus Otv-S500 (Olympus Otv-S500)Olympus Medical Systems Corporation20250—
+4K242108Ambu® aScope™ 5 Uretero (Standard Deflection); Ambu® aScope™ 5 Uretero (Reverse…Ambu A/S20240—
+4K241371Visera S Video System Center Olympus Otv-S500 (Olympus Otv-S500)Olympus Medical Systems Corporation20240—
+4K232860PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Bronchoscope EB11-J10…Pentax of America, Inc.20241—
+4K232249PENTAX Medical Gas/Water Feeding Valve OE-B14Pentax of America, Inc.20230—
+4K232244Disposable Endoscope Valves SystemChangzhou Endoclean Medical Device Co., Ltd.20230—
+4K232028Q Vision Sterile Single Use Adult Flexible Gastroscope (G-100); Q Base Reusable Base…Iq Endoscopes Limited20230—
+4K222584Evis X1 Video System Center Olympus CV-1500, Colonovideoscope Olympus CF-HQ1100DL/I…Olympus Medical Systems Corporation202321
+4K222020HD-550 Video Endoscope SystemSonoscape Medical Corp.20220—
+4K210116Video Endoscopy System, 3D Video Endoscopy SystemSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.20210—
+4K212667Single Use Guide Sheath Kit-401, K-402Olympus Medical Systems Corp.20210—
+4K201758EVIS EXERA III Bronchovideoscope Olympus BF-XP190, EVIS EXERA III Bronchovideoscope…Olympus Medical Systems Corp.20211Class I
+4K201526TIPCAM1 Rubina Video Endoscope SystemKarl Storz Endoscopy America20205—
+4K202646Visera Elite II Video System CenterOlympus Medical Systems Corp.20200—
+4K192793Evis Exera III Colonovideoscope Olympus PCF-H190TL, Evis Exera III Colonovideoscope…Olympus Medical Systems Corp.202003
+4K192286FUJIFILM EP-6000 Video ProcessorFujifilm Corporation20200—
+4K192588G-EYE SystemSmart Medical Systems, Ltd.20202—
+4K192918Video Laparoscope, Video Processor, Light SourceFujifilm Corporation20206—
+4K193202EXALT Model D Single-Use Duodenoscope, EXALT ControllerBoston Scientific Corporation201946
+4K160275Fuse Endoscopic System with FuseBox ProcessorEndochoice, Inc.20160—
+5K261880FUJIFILM Processor EP-8000;Balloon Controller PB-30;Endoscopy Support Program EW10-VM01Fujifilm Corporation20260—
+5K243261FUJIFILM Endoscope Model EC-860P/M; FUJIFILM Endoscope Model EC-860P/L; FUJIFILM…Fujifilm Corporation20250—
+5K250432Colonovideoscope (CF-EZ1500DL); Colonovideoscope (CF-EZ1500DI); Gastrointestinal…Olympus Medical Systems Corporation20250—
+5K233942PENTAX Medical Video Duodenoscope (ED34-i10T2s); PENTAX Medical Video Processor…Pentax of America, Inc.20240—
+5K223759Arthrex SynergyID Endoscopic Imaging SystemArthex, Inc.20234—
+5K213606EvoEndo Single-Use Endoscopy SystemEvoEndo, Inc.20223—
+5K203717Processor VP-7000, Light Source BL-7000X, Image Processing Unit EX-0Fujifilm Corporaton20213—
+5K202469G-EYE SystemSmart Medical Systems, Ltd.20201—
+5K202130FUJIFILM Video LaparoscopeFujifilm Corporation20201—
+6K251708EvoEndo Single-Use Endoscopy SystemEvoEndo, Inc.20251—
+6K250268HyperSnap Surgical System (HSS)Hypervision Surgical20251—
+6K250900EvoEndo Single-Use Endoscopy SystemEvoEndo, Inc.20250—
+6K233225SCHOELLY Oxygen Saturation Imaging (OSI) Camera System (Camera Control Unit, Camera Head…Schoelly Fiberoptic GmbH20240—
+6K233451Arthrex Synergy Vision Endoscopic Imaging SystemArthrex, Inc.20243—
+6K220158G-EYE SystemSmart Medical Systems, Ltd.20220—
+6K212950FUJIFILM Video Laparoscope EL-R740M30Fujifilm Corporaton20210—
+7K253984Instrument Exit Point on Touch Surgery™ AideCovidien, LLC20260—
+7K260573EvoEndo Single-Use Endoscopy SystemEvoEndo, Inc.20260—
+7K241361Arthrex Synergy Vision Endoscopic Imaging SystemArthrex, Inc.20242—
+8K250728Arthrex Synergy Vision Endoscopic Imaging SystemArthrex, Inc.20251—
+9K251994Arthrex Synergy Vision Imaging SystemArthrex, Inc.20250—