510(k) Report

Devices descending from K853585

320 later devices reach Olympus Evs-Endoscopic Video Image & Data Sys through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K233225SCHOELLY Oxygen Saturation Imaging (OSI) Camera System (Camera Control Unit, Camera Head…Schoelly Fiberoptic GmbH20240—
+8K240283BubbleView™ Single-Use Digital Flexible Cystoscope (C50-C, C50-CR, C50-CB, C50-CBR)…MacroLux Medical Technology Co., Ltd.20240—
+8K233451Arthrex Synergy Vision Endoscopic Imaging SystemArthrex, Inc.20243—
+8K231702WiScope® Digital Cystoscope System, WiScope® Single-Use Digital Flexible Cystoscope…OTU Medical, Inc.20230—
+8K230909EchoTip® AcuCore™ Ultrasound Biopsy Needle (ECHO-BX-3-22)Cook Ireland, Ltd.20231—
+8K221238FUJIFILM Ultrasonic Endoscope EG-740UTFujifilm Corporation20220—
+8K221952Endoscope Model EG-580UT and Endoscope Model EG-580URFujifilm Corporation20220—
+8K213060AreusTM Endobronchial Ultrasound Aspiration Needle, TridentTM Endobronchial Ultrasound…Micro-Tech (Nanjing) Co., Ltd.20221—
+8K220158G-EYE SystemSmart Medical Systems, Ltd.20220—
+8K212950FUJIFILM Video Laparoscope EL-R740M30Fujifilm Corporaton20210—
+8K212322Cellvizio I.V.E. system with Confocal MiniprobesMauna Kea Technologies20210—
+8K203166PENTAX Medical Ultrasound Upper GI Video Scope EG34-J10U, PENTAX Medical Ultrasound…Pentax of America, Inc.20200—
+8K190239Single Use Aspiration NeedleOlympus Medical Systems Corp.20192—
+9K253984Instrument Exit Point on Touch Surgery™ AideCovidien, LLC20260—
+9K251478ClearTip TBNA TypeFinemedix Co., Ltd.20260—
+9K251664Single Use Aspiration Needle (NA-201SX-4021); Single Use Aspiration Needle (NA-201SX-4022)Olympus Medical Systems Corporation20250—
+9K241361Arthrex Synergy Vision Endoscopic Imaging SystemArthrex, Inc.20242—
+9K230778EndoCorePraxis Medical, LLC20230—
+10K250728Arthrex Synergy Vision Endoscopic Imaging SystemArthrex, Inc.20251—
+11K251994Arthrex Synergy Vision Imaging SystemArthrex, Inc.20250—