510(k) Report

Devices descending from K051645

208 later devices reach Evis Exera 160A System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K231702WiScope® Digital Cystoscope System, WiScope® Single-Use Digital Flexible Cystoscope…OTU Medical, Inc.20230—
+6K220158G-EYE SystemSmart Medical Systems, Ltd.20220—
+6K212950FUJIFILM Video Laparoscope EL-R740M30Fujifilm Corporaton20210—
+6K212322Cellvizio I.V.E. system with Confocal MiniprobesMauna Kea Technologies20210—
+7K253984Instrument Exit Point on Touch Surgery™ AideCovidien, LLC20260—
+7K241361Arthrex Synergy Vision Endoscopic Imaging SystemArthrex, Inc.20242—
+8K250728Arthrex Synergy Vision Endoscopic Imaging SystemArthrex, Inc.20251—
+9K251994Arthrex Synergy Vision Imaging SystemArthrex, Inc.20250—