510(k) Report

Devices descending from K954451

318 later devices reach Evis 140 System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K233451Arthrex Synergy Vision Endoscopic Imaging SystemArthrex, Inc.20243—
+7K231702WiScope® Digital Cystoscope System, WiScope® Single-Use Digital Flexible Cystoscope…OTU Medical, Inc.20230—
+7K230909EchoTip® AcuCore™ Ultrasound Biopsy Needle (ECHO-BX-3-22)Cook Ireland, Ltd.20231—
+7K221238FUJIFILM Ultrasonic Endoscope EG-740UTFujifilm Corporation20220—
+7K221952Endoscope Model EG-580UT and Endoscope Model EG-580URFujifilm Corporation20220—
+7K213060AreusTM Endobronchial Ultrasound Aspiration Needle, TridentTM Endobronchial Ultrasound…Micro-Tech (Nanjing) Co., Ltd.20221—
+7K220158G-EYE SystemSmart Medical Systems, Ltd.20220—
+7K212950FUJIFILM Video Laparoscope EL-R740M30Fujifilm Corporaton20210—
+7K212322Cellvizio I.V.E. system with Confocal MiniprobesMauna Kea Technologies20210—
+7K203166PENTAX Medical Ultrasound Upper GI Video Scope EG34-J10U, PENTAX Medical Ultrasound…Pentax of America, Inc.20200—
+7K190239Single Use Aspiration NeedleOlympus Medical Systems Corp.20192—
+8K253984Instrument Exit Point on Touch Surgery™ AideCovidien, LLC20260—
+8K251478ClearTip TBNA TypeFinemedix Co., Ltd.20260—
+8K251664Single Use Aspiration Needle (NA-201SX-4021); Single Use Aspiration Needle (NA-201SX-4022)Olympus Medical Systems Corporation20250—
+8K241361Arthrex Synergy Vision Endoscopic Imaging SystemArthrex, Inc.20242—
+8K230778EndoCorePraxis Medical, LLC20230—
+9K250728Arthrex Synergy Vision Endoscopic Imaging SystemArthrex, Inc.20251—
+10K251994Arthrex Synergy Vision Imaging SystemArthrex, Inc.20250—