510(k) Report

Devices descending from K033225

60 later devices reach Evis Exera Bronchofibervideoscope Olympus BF Type XP160F, Its Accessories and… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K082720Tracheal Intubation Fibervideoscope, Models LF-Y0004 and LF-Y0005Olympus Medical Systems Corporation200813
+1K051886Olympus Choledochoscope, Model XCHF-BP160FOlympus Medical Systems Corporation200513—
+1K042140Olympus BF Type UC160-OL8Olympus Corporation2004431
+2K201300Airway MobilescopeOlympus Medical Systems Corp.202102
+2K123704Automated Endoscope Leak TesterOlympus Medical Systems Corp.20131—
+2K121035Fujinon/Fujifilm Ultrasonic Endoscope EB-530USFujifilm Medical System U.S.A., Inc.20122—
+2K090170Spyscope Access and Delivery CatheterBoston Scientific Corp200910—
+2K070983Olympus XBF-UC180F-DT8 Ultrasonic Bronchofibervideoscope Used with Aloka SSD-Alpha 5/10…Olympus Medical Systems Corporation2007113
+2K050503Single Use Aspiration Needle NA-201SX-4022Olympus Medical Systems Corporation2005285
+3K250863FUJIFILM Ultrasonic Endoscope EB-710USFujifilm Corporation20250—
+3K212201PENTAX Medical Auto Leakage Tester SHA-P6Pentax of America, Inc.20210—
+3K203128Evis Eus Endoscopic Ultrasound Center Olympus EU-ME2/Evis Eus Endoscopic Ultrasound…Olympus Medical Systems Corp.20201—
+3K183525EVIS EUS Ultrasound Bronchofibervideoscope Olympus BF-UC190FOlympus Medical Systems Corp.201921
+3K182825FUJIFILM Ultrasonic EndoscopeFujifilm Corporation20190—
+3K160098Single Use Aspiration Needle NA-U401SXOlympus Medical Systems Corp.201612
+3K151315Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration NeedleBoston Scientific Corporation20153—
+3K151895Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration NeedleBoston Scientific Corporation20150—
+3K142909Flexible 19G EBUS NeedleSpiration, Inc.20157—
+3K142922SpyGlass DS Direct Visualization SystemBoston Scientific Corporation201591
+3K093195Echotip Ultra Endobronchial High Definition Ultasound Needle, Model: Echo-HD-22-Ebus-OCook Ireland, Ltd.20108—
+3K091257Medi-Globe Sonotip II Ebus-Tbna Needle SystemMedi-Globe Corporation20093—
+3K081518Ultrasound Video Bronchoscope, Model EB-1970UKPentax Medical Company20085—
+4K260401Evis Eus Ultrasound Bronchofibervideoscope Olympus BF-UCP190F (BF-UCP190F)Olympus Medical Systems Corporation20260—
+4K254153Single-use Video Scope; PB Digital ControllerMirco-Tech (Nanjing) Co., Ltd.20260—
+4K241444Biliary Pancreaticobiliary Scope SystemShenzhen HugeMed Medical Technical Development Co., Ltd.20250—
+4K243502Evis Eus Endoscopic Ultrasound Center Olympus EU-ME3 (Olympus EU-ME3)Olympus Medical Systems Corporation20250—
+4K221784Single-use Video Pancreaticobiliary Scope, PB Digital ControllerMicro-Tech (Nanjing) Co., Ltd.20232—
+4K180668Single Use Aspiration Needle NA-U401SX-4025/NA-U401SX-4025NOlympus Medical Systems Corp.20180—
+4K181439SpyGlass DS and DS II Direct Visualization SystemBoston Scientific Corporation20187—
+4K173554PENTAX Medical Video Bronchoscopes, PENTAX Medical Video Naso-Pharyngo-Laryngoscope, and…Pentax of America, Inc.20180—
+4K163248Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration NeedleBoston Scientific Corporation20172—
+4K160229Echotip Ultra Endobronchial High Definition Ultrasound Needle, Echotip Procore…Cook Ireland, Ltd.20167—
+4K152922ViziShot FLEXSpiration, Inc.20166—
+4K133763Sonotip Pro and Pro Flex Ebus-Tbna Needle SystemMedi-Globe Corporation20142—
+4K131946Entax Ultrasound Video Bronchoscope EB-1970UK + HI Visin PreirusPentax Medical Company201434
+5K252492Visualized Access and Delivery Catheter; PB Digital ControllerMicro-Tech (Nanjing) Co., Ltd.20260—
+5K250145Biopsy Port AdapterEndosound, Inc.20250—
+5K233752Dragonfly™ Pancreaticobiliary Scope; Dragonfly™ Digital Controller; Dragonfly™…CenterPoint Systems, LLC20240—
+5K231267ClearTipFinemedix Co., Ltd.20231—
+5K210476EchoTip Ultra Endoscopic Ultrasound Needle, EchoTip ProCore HD Ultrasound Biopsy Needle…Cook Ireland, Ltd.202121
+5K193517ViziShot 2 FLEXOlympus Surgical Technologies America20202Class I
+5K183516PENTAX Medical Ultrasound Video Bronchoscope EB19-J10UPentax of America, Inc.20191—
+5K183654PENTAX Medical EB-1970UK Ultrasound Video Bronchoscope + Hitachi NOBLUS and HI VISION…Pentax of America, Inc.20190—
+5K183085CoreDx™ Pulmonary Mini-ForcepsBoston Scientific Corporation20190—
+5K183636SpyScope DS Access and Delivery Catheter, SpyScope DS II Access and Delivery Catheter…Boston Scientific Corporation20195—
+5K171956Sterile Endoscope Biopsy Sampling NeedleChangzhou Detain Medical Devices Co., Ltd.20170—
+5K163469ViziShot 2 FLEXOlympus Surgical Technologies America20175—
+6K261274EchoTip Ultra® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes; EchoTip…Cook Ireland, Ltd.20260—
+6K251338Cholangioscope Visualization System (Single-use Video Cholangioscope: SCV-P-01G…Scivita Medical Technology Co., Ltd.20260—
+6K251402LIA-1 Catheter (542-1)Leadoptik, Inc.20250—
+6K250994ClearTip FNA and FNB TypesFinemedix Co., Ltd.20250—
+6K241209EchoTip AcuCore™ EUS Biopsy Needle (ECHO-BX-19)Cook Ireland, Ltd.20240—
+6K230909EchoTip® AcuCore™ Ultrasound Biopsy Needle (ECHO-BX-3-22)Cook Ireland, Ltd.20231—
+6K213060AreusTM Endobronchial Ultrasound Aspiration Needle, TridentTM Endobronchial Ultrasound…Micro-Tech (Nanjing) Co., Ltd.20221—
+6K203166PENTAX Medical Ultrasound Upper GI Video Scope EG34-J10U, PENTAX Medical Ultrasound…Pentax of America, Inc.20200—
+6K200483SpyGlass Discover Digital Catheter, SpyGlass Discover Digital ControllerBoston Scientific Corporation20203—
+6K190239Single Use Aspiration NeedleOlympus Medical Systems Corp.20192—
+7K251478ClearTip TBNA TypeFinemedix Co., Ltd.20260—
+7K251664Single Use Aspiration Needle (NA-201SX-4021); Single Use Aspiration Needle (NA-201SX-4022)Olympus Medical Systems Corporation20250—
+7K230778EndoCorePraxis Medical, LLC20230—