510(k) Report

Devices descending from K042140

43 later devices reach Olympus BF Type UC160-OL8 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K121035Fujinon/Fujifilm Ultrasonic Endoscope EB-530USFujifilm Medical System U.S.A., Inc.20122—
+1K070983Olympus XBF-UC180F-DT8 Ultrasonic Bronchofibervideoscope Used with Aloka SSD-Alpha 5/10…Olympus Medical Systems Corporation2007113
+1K050503Single Use Aspiration Needle NA-201SX-4022Olympus Medical Systems Corporation2005285
+2K250863FUJIFILM Ultrasonic Endoscope EB-710USFujifilm Corporation20250—
+2K203128Evis Eus Endoscopic Ultrasound Center Olympus EU-ME2/Evis Eus Endoscopic Ultrasound…Olympus Medical Systems Corp.20201—
+2K183525EVIS EUS Ultrasound Bronchofibervideoscope Olympus BF-UC190FOlympus Medical Systems Corp.201921
+2K182825FUJIFILM Ultrasonic EndoscopeFujifilm Corporation20190—
+2K160098Single Use Aspiration Needle NA-U401SXOlympus Medical Systems Corp.201612
+2K151315Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration NeedleBoston Scientific Corporation20153—
+2K151895Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration NeedleBoston Scientific Corporation20150—
+2K142909Flexible 19G EBUS NeedleSpiration, Inc.20157—
+2K093195Echotip Ultra Endobronchial High Definition Ultasound Needle, Model: Echo-HD-22-Ebus-OCook Ireland, Ltd.20108—
+2K091257Medi-Globe Sonotip II Ebus-Tbna Needle SystemMedi-Globe Corporation20093—
+2K081518Ultrasound Video Bronchoscope, Model EB-1970UKPentax Medical Company20085—
+3K260401Evis Eus Ultrasound Bronchofibervideoscope Olympus BF-UCP190F (BF-UCP190F)Olympus Medical Systems Corporation20260—
+3K243502Evis Eus Endoscopic Ultrasound Center Olympus EU-ME3 (Olympus EU-ME3)Olympus Medical Systems Corporation20250—
+3K180668Single Use Aspiration Needle NA-U401SX-4025/NA-U401SX-4025NOlympus Medical Systems Corp.20180—
+3K173554PENTAX Medical Video Bronchoscopes, PENTAX Medical Video Naso-Pharyngo-Laryngoscope, and…Pentax of America, Inc.20180—
+3K163248Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration NeedleBoston Scientific Corporation20172—
+3K160229Echotip Ultra Endobronchial High Definition Ultrasound Needle, Echotip Procore…Cook Ireland, Ltd.20167—
+3K152922ViziShot FLEXSpiration, Inc.20166—
+3K133763Sonotip Pro and Pro Flex Ebus-Tbna Needle SystemMedi-Globe Corporation20142—
+3K131946Entax Ultrasound Video Bronchoscope EB-1970UK + HI Visin PreirusPentax Medical Company201434
+4K250145Biopsy Port AdapterEndosound, Inc.20250—
+4K231267ClearTipFinemedix Co., Ltd.20231—
+4K210476EchoTip Ultra Endoscopic Ultrasound Needle, EchoTip ProCore HD Ultrasound Biopsy Needle…Cook Ireland, Ltd.202121
+4K193517ViziShot 2 FLEXOlympus Surgical Technologies America20202Class I
+4K183516PENTAX Medical Ultrasound Video Bronchoscope EB19-J10UPentax of America, Inc.20191—
+4K183654PENTAX Medical EB-1970UK Ultrasound Video Bronchoscope + Hitachi NOBLUS and HI VISION…Pentax of America, Inc.20190—
+4K183085CoreDx™ Pulmonary Mini-ForcepsBoston Scientific Corporation20190—
+4K171956Sterile Endoscope Biopsy Sampling NeedleChangzhou Detain Medical Devices Co., Ltd.20170—
+4K163469ViziShot 2 FLEXOlympus Surgical Technologies America20175—
+5K261274EchoTip Ultra® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes; EchoTip…Cook Ireland, Ltd.20260—
+5K251402LIA-1 Catheter (542-1)Leadoptik, Inc.20250—
+5K250994ClearTip FNA and FNB TypesFinemedix Co., Ltd.20250—
+5K241209EchoTip AcuCore™ EUS Biopsy Needle (ECHO-BX-19)Cook Ireland, Ltd.20240—
+5K230909EchoTip® AcuCore™ Ultrasound Biopsy Needle (ECHO-BX-3-22)Cook Ireland, Ltd.20231—
+5K213060AreusTM Endobronchial Ultrasound Aspiration Needle, TridentTM Endobronchial Ultrasound…Micro-Tech (Nanjing) Co., Ltd.20221—
+5K203166PENTAX Medical Ultrasound Upper GI Video Scope EG34-J10U, PENTAX Medical Ultrasound…Pentax of America, Inc.20200—
+5K190239Single Use Aspiration NeedleOlympus Medical Systems Corp.20192—
+6K251478ClearTip TBNA TypeFinemedix Co., Ltd.20260—
+6K251664Single Use Aspiration Needle (NA-201SX-4021); Single Use Aspiration Needle (NA-201SX-4022)Olympus Medical Systems Corporation20250—
+6K230778EndoCorePraxis Medical, LLC20230—