510(k) Report

Devices descending from K072957

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K251861FUJIFILM Endoscope Model ED-S100TP; FUJIFILM Endoscope Model ED-S100XP; FUJIFILM…Fujifilm Corporation20260—
+1K250550FUJIFILM Endoscope Model EG-S100XT and VS-1000 Display UnitFujifilm Corporation20260—
+1K172246Olympus Urf-V2/V2ROlympus Medical Systems Corp.201823
+1K091962Polyscope Flexible Endoscopy Catheter; 10,000 Pixel Fiber Optic; Xenon Light Source…Lumenis, Inc.200911—
+2K181451Uretero-Reno Videoscope Olympus Urf-V3/V3R, Uretero-Reno Fiberscope Olympus Urf-P7/P7ROlympus Medical Systems Corp.201911
+2K132389Cellvizio 100 Series System and Cellvizio System with Confocal Miniprobes; Uroflex B and…Daniel & Daniel Consulting201410—
+3K191078BAROnova Access Sheath KitBaronova, Inc.20190—
+3K150831Cellvizio 100 Series System with Confocal MiniprobesMauna Kea Technologies20157—
+3K141358Cellvizio 100 Series with System Confocal MiniprobesMauna Kea Technologies20149—
+4K183640Cellvizio 100 Series Confocal laser Imaging systems and their Confocal MiniprobesMauna Kea Technologies20194—
+4K172844Cellvizio 100 Series System with Confocal MiniprobesMauna Kea Technologies20176—
+4K160416CystoFlex UHD R-C, CelioFlex UHD 5-C, Cellvizio 100 Series (800) with Confocal MiniprobesMauna Kea Technologies20167—
+5K241275Histolog® Scanner (Hardware 2.4, Software 3.3)Samantree Medical SA20240—
+5K193416Cellvizio I.V.E. with Confocal MiniprobesMauna Kea Technologies20200—
+5K191144Cellvizio 100 Series System with Confocal MiniprobesMauna Kea Technologies20202—
+6K243711Confocal Microprobe Imaging System (BrightP980); Confocal Microprobe Imaging System…Wuxi Hisky Medical Technologies Co., Ltd.20250—
+6K212322Cellvizio I.V.E. system with Confocal MiniprobesMauna Kea Technologies20210—