510(k) Report

Devices descending from K100584

132 later devices reach Evis Exeraii 180 System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K150525SPIES 3D Tip Cam, Image 1 SPIES CCU Image Connect, Image 1 SPIES CCU D-3 LinkKARL STORZ Endoscopy-America, Inc.20157—
+4K2620794K Camera Head OLYMPUS CH-S700-08-LBOlympus Medical Systems Corp.20260—
+4K261880FUJIFILM Processor EP-8000;Balloon Controller PB-30;Endoscopy Support Program EW10-VM01Fujifilm 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—
+4K250939SIRIUS Endoscope System (PR-SI-1230)Precision Robotics (Hong Kong) Limited20250—
+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—
+4K232860PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Bronchoscope EB11-J10…Pentax of America, Inc.20241—
+4K213606EvoEndo Single-Use Endoscopy SystemEvoEndo, Inc.20223—
+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—
+4K203717Processor VP-7000, Light Source BL-7000X, Image Processing Unit EX-0Fujifilm Corporaton20213—
+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—
+4K202469G-EYE SystemSmart Medical Systems, Ltd.20201—
+4K202130FUJIFILM Video LaparoscopeFujifilm Corporation20201—
+5K251708EvoEndo Single-Use Endoscopy SystemEvoEndo, Inc.20251—
+5K250268HyperSnap Surgical System (HSS)Hypervision Surgical20251—
+5K250900EvoEndo Single-Use Endoscopy SystemEvoEndo, Inc.20250—
+5K233942PENTAX Medical Video Duodenoscope (ED34-i10T2s); PENTAX Medical Video Processor…Pentax of America, Inc.20240—
+5K233225SCHOELLY Oxygen Saturation Imaging (OSI) Camera System (Camera Control Unit, Camera Head…Schoelly Fiberoptic GmbH20240—
+5K223759Arthrex SynergyID Endoscopic Imaging SystemArthex, Inc.20234—
+5K220158G-EYE SystemSmart Medical Systems, Ltd.20220—
+5K212950FUJIFILM Video Laparoscope EL-R740M30Fujifilm Corporaton20210—
+6K253984Instrument Exit Point on Touch Surgery™ AideCovidien, LLC20260—
+6K260573EvoEndo Single-Use Endoscopy SystemEvoEndo, Inc.20260—
+6K233451Arthrex Synergy Vision Endoscopic Imaging SystemArthrex, Inc.20243—
+7K241361Arthrex Synergy Vision Endoscopic Imaging SystemArthrex, Inc.20242—
+8K250728Arthrex Synergy Vision Endoscopic Imaging SystemArthrex, Inc.20251—
+9K251994Arthrex Synergy Vision Imaging SystemArthrex, Inc.20250—