510(k) Report

Devices descending from K980302

19 later devices reach Working Elements, Resectoscope Sheaths, Electrodes, Obturators, Endoscopes through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K102663Aed ResectoscopeNational Advanced Endoscopy Devices, Inc.20100—
+1K062720S-Line Bipolar Resectoscopes and Bipolar ElectrodesRichard Wolf Medical Instruments Corp.200722
+1K050910Roei Working Element and Roel Cutting LoopsRoei Medical Technologies, Ltd.20051—
+1K011496Cysto-Urethroscopes E-Line Existing of: Sheaths, Obturators, Inserts, Attchements, and…Richard Wolf Medical Instruments Corp.200112—
+2K260649OES ELITE Cystoscope and Accessories; Obturator, 17 Fr. (WA2C17BO); Obturator, 19.8 Fr.…Olympus Winter & Ibe GmbH20260—
+2K191341Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion…Corinth Medtech, Inc.20191—
+2K132389Cellvizio 100 Series System and Cellvizio System with Confocal Miniprobes; Uroflex B and…Daniel & Daniel Consulting201410—
+2K053322Modification to: Roei Working Element and Roei Cutting LoopsRoei Medical Technologies, Ltd.20060—
+3K250522Multi4 SystemMulti4 Medical AB20250—
+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—