510(k) Report

Devices descending from K970427

13 later devices reach Ksea Uretero-Reno-Fiberscope and Nephro-Fiberscope through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K043022Stryker Flexible CystonephroscopeStryker Endoscopy200511—
+1K031278Stryker Flexible UreteroscopeStryker Endoscopy20030—
+2K132389Cellvizio 100 Series System and Cellvizio System with Confocal Miniprobes; Uroflex B and…Daniel & Daniel Consulting201410—
+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—