510(k) Report

Devices descending from K011496

12 later devices reach Cysto-Urethroscopes E-Line Existing of: Sheaths, Obturators, Inserts… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K260649OES ELITE Cystoscope and Accessories; Obturator, 17 Fr. (WA2C17BO); Obturator, 19.8 Fr.…Olympus Winter & Ibe GmbH20260—
+1K132389Cellvizio 100 Series System and Cellvizio System with Confocal Miniprobes; Uroflex B and…Daniel & Daniel Consulting201410—
+2K150831Cellvizio 100 Series System with Confocal MiniprobesMauna Kea Technologies20157—
+2K141358Cellvizio 100 Series with System Confocal MiniprobesMauna Kea Technologies20149—
+3K183640Cellvizio 100 Series Confocal laser Imaging systems and their Confocal MiniprobesMauna Kea Technologies20194—
+3K172844Cellvizio 100 Series System with Confocal MiniprobesMauna Kea Technologies20176—
+3K160416CystoFlex UHD R-C, CelioFlex UHD 5-C, Cellvizio 100 Series (800) with Confocal MiniprobesMauna Kea Technologies20167—
+4K241275Histolog® Scanner (Hardware 2.4, Software 3.3)Samantree Medical SA20240—
+4K193416Cellvizio I.V.E. with Confocal MiniprobesMauna Kea Technologies20200—
+4K191144Cellvizio 100 Series System with Confocal MiniprobesMauna Kea Technologies20202—
+5K243711Confocal Microprobe Imaging System (BrightP980); Confocal Microprobe Imaging System…Wuxi Hisky Medical Technologies Co., Ltd.20250—
+5K212322Cellvizio I.V.E. system with Confocal MiniprobesMauna Kea Technologies20210—