510(k) Report

Devices descending from K011886

60 later devices reach Olympus EU-M60 Eus Exera Endoscopic Ultrasound CTR, Eus Exera Ultrasonic… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K063683Olympus Xeu-M60A Endoscopic Ultrasound Center; XGF-UM180 Ultrasonic GastrovideoscopeOlympus Medical Systems Corporation200715—
+1K043275Olympus EU-M60 Eus Exera Endoscopic Ultrasound CenterOlympus Medical Systems Corporation200416—
+1K021204Olympus BF Type UM40Olympus Optical Co., Ltd.200244—
+2K121564Endoscopic Ultrasound Center EU-Y0006Olympus Medical Systems Corp.20126—
+2K092156Cad 12, Colonoscopy Assist DeviceSoftscope Medical Technologies, Inc.20097—
+2K042140Olympus BF Type UC160-OL8Olympus Corporation2004431
+3K221340iNod Ultrasound Guided Biopsy Needle (UPN: M00502060), iNod Ultrasound Guidance Console…Boston Scientific Corporation20230—
+3K203128Evis Eus Endoscopic Ultrasound Center Olympus EU-ME2/Evis Eus Endoscopic Ultrasound…Olympus Medical Systems Corp.20201—
+3K130058Endoscopic Ultrasound Center EU-Y0008Olympus Medical Systems Corp.20134—
+3K121035Fujinon/Fujifilm Ultrasonic Endoscope EB-530USFujifilm Medical System U.S.A., Inc.20122—
+3K100624Invendo C20 Colonoscopy SystemInvendo Medical Gbmh20126—
+3K070983Olympus XBF-UC180F-DT8 Ultrasonic Bronchofibervideoscope Used with Aloka SSD-Alpha 5/10…Olympus Medical Systems Corporation2007113
+3K050503Single Use Aspiration Needle NA-201SX-4022Olympus Medical Systems Corporation2005285
+4K250863FUJIFILM Ultrasonic Endoscope EB-710USFujifilm Corporation20250—
+4K243502Evis Eus Endoscopic Ultrasound Center Olympus EU-ME3 (Olympus EU-ME3)Olympus Medical Systems Corporation20250—
+4K183525EVIS EUS Ultrasound Bronchofibervideoscope Olympus BF-UC190FOlympus Medical Systems Corp.201921
+4K182825FUJIFILM Ultrasonic EndoscopeFujifilm Corporation20190—
+4K171207FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-MFujifilm Medical Systems U.S.A, Inc.20181—
+4K161355invendoscopy E200 SystemInvendo Medical GmbH20161—
+4K161791Aer-O-Scope Colonoscope SystemGi View, Ltd.20160—
+4K160098Single Use Aspiration Needle NA-U401SXOlympus Medical Systems Corp.201612
+4K151315Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration NeedleBoston Scientific Corporation20153—
+4K151895Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration NeedleBoston Scientific Corporation20150—
+4K142909Flexible 19G EBUS NeedleSpiration, Inc.20157—
+4K141286Aer-O-Scope Colonoscope SystemGi View, Ltd.20142—
+4K121582Invendo C25 Colonoscopy SystemInvendo Medical Gbmh20125—
+4K093195Echotip Ultra Endobronchial High Definition Ultasound Needle, Model: Echo-HD-22-Ebus-OCook Ireland, Ltd.20108—
+4K091257Medi-Globe Sonotip II Ebus-Tbna Needle SystemMedi-Globe Corporation20093—
+4K081518Ultrasound Video Bronchoscope, Model EB-1970UKPentax Medical Company20085—
+5K260401Evis Eus Ultrasound Bronchofibervideoscope Olympus BF-UCP190F (BF-UCP190F)Olympus Medical Systems Corporation20260—
+5K214089FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M2Fujifilm Corporation20220—
+5K190669EndoticsEra Endoscopy S.R.L.20200—
+5K180668Single Use Aspiration Needle NA-U401SX-4025/NA-U401SX-4025NOlympus Medical Systems Corp.20180—
+5K173554PENTAX Medical Video Bronchoscopes, PENTAX Medical Video Naso-Pharyngo-Laryngoscope, and…Pentax of America, Inc.20180—
+5K173085invendoscopy E210 SystemInvendo Medical GmbH20180—
+5K163248Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration NeedleBoston Scientific Corporation20172—
+5K160229Echotip Ultra Endobronchial High Definition Ultrasound Needle, Echotip Procore…Cook Ireland, Ltd.20167—
+5K152922ViziShot FLEXSpiration, Inc.20166—
+5K133763Sonotip Pro and Pro Flex Ebus-Tbna Needle SystemMedi-Globe Corporation20142—
+5K131946Entax Ultrasound Video Bronchoscope EB-1970UK + HI Visin PreirusPentax Medical Company201434
+6K250145Biopsy Port AdapterEndosound, Inc.20250—
+6K231267ClearTipFinemedix Co., Ltd.20231—
+6K210476EchoTip Ultra Endoscopic Ultrasound Needle, EchoTip ProCore HD Ultrasound Biopsy Needle…Cook Ireland, Ltd.202121
+6K193517ViziShot 2 FLEXOlympus Surgical Technologies America20202Class I
+6K183516PENTAX Medical Ultrasound Video Bronchoscope EB19-J10UPentax of America, Inc.20191—
+6K183654PENTAX Medical EB-1970UK Ultrasound Video Bronchoscope + Hitachi NOBLUS and HI VISION…Pentax of America, Inc.20190—
+6K183085CoreDx™ Pulmonary Mini-ForcepsBoston Scientific Corporation20190—
+6K171956Sterile Endoscope Biopsy Sampling NeedleChangzhou Detain Medical Devices Co., Ltd.20170—
+6K163469ViziShot 2 FLEXOlympus Surgical Technologies America20175—
+7K261274EchoTip Ultra® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes; EchoTip…Cook Ireland, Ltd.20260—
+7K251402LIA-1 Catheter (542-1)Leadoptik, Inc.20250—
+7K250994ClearTip FNA and FNB TypesFinemedix Co., Ltd.20250—
+7K241209EchoTip AcuCore™ EUS Biopsy Needle (ECHO-BX-19)Cook Ireland, Ltd.20240—
+7K230909EchoTip® AcuCore™ Ultrasound Biopsy Needle (ECHO-BX-3-22)Cook Ireland, Ltd.20231—
+7K213060AreusTM Endobronchial Ultrasound Aspiration Needle, TridentTM Endobronchial Ultrasound…Micro-Tech (Nanjing) Co., Ltd.20221—
+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—
+8K251478ClearTip TBNA TypeFinemedix Co., Ltd.20260—
+8K251664Single Use Aspiration Needle (NA-201SX-4021); Single Use Aspiration Needle (NA-201SX-4022)Olympus Medical Systems Corporation20250—
+8K230778EndoCorePraxis Medical, LLC20230—