510(k) Report

Devices descending from K812810

87 later devices reach Pentax Flexible Driodenofiberscope through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K961974FG-36UX, Ultrasound Upper GI FiberscopePentax Precision Instrument Corp.1997862
+2K013640EG-3630UR, Ultrasund Video GastroscopePentax Precision Instrument Corp.20029—
+2K010740FG-36UX, Fiber Ultrasound GastroscopePentax Precision Instrument Corp.200116—
+2K010591Olympus EU-C60 Eus Exera Compact Endoscopic Ultrasound CenterOlympus Optical Co., Ltd.2001592
+3K063847Fujinon Ultrasonic Endoscope and Processor, Models EG-530UR, EG-530UT and SU-700Fujinon, Inc.200781
+3K063683Olympus Xeu-M60A Endoscopic Ultrasound Center; XGF-UM180 Ultrasonic GastrovideoscopeOlympus Medical Systems Corporation200715—
+3K042140Olympus BF Type UC160-OL8Olympus Corporation2004431
+3K041395EG-3630URPentax Precision Instrument Corp.20044—
+3K031347Ultrasonic Gastrovideoscope, Type UC160P-AT8 and UCT160-AT8Olympus Optical Co., Ltd.200344—
+3K021278EG-3630UR, Ultrasound Video GastroscopePentax Precision Instrument Corp.200210—
+4K121564Endoscopic Ultrasound Center EU-Y0006Olympus Medical Systems Corp.20126—
+4K120446Fujinon/Fujifilm Ultrasonic Endoscope EG-530UR2 and EG-530UT2Fujinon, Inc.201241
+4K121035Fujinon/Fujifilm Ultrasonic Endoscope EB-530USFujifilm Medical System U.S.A., Inc.20122—
+4K111243Fujinon Ultrasonic ProcessorFujinon, Inc.20117—
+4K092156Cad 12, Colonoscopy Assist DeviceSoftscope Medical Technologies, Inc.20097—
+4K070983Olympus XBF-UC180F-DT8 Ultrasonic Bronchofibervideoscope Used with Aloka SSD-Alpha 5/10…Olympus Medical Systems Corporation2007113
+4K061068EG-3670URKPentax Medical Company200631
+4K050503Single Use Aspiration Needle NA-201SX-4022Olympus Medical Systems Corporation2005285
+4K023401EG-3830UT, Video Ultrasound GastroscopePentax Precision Instrument Corp.20039—
+5K250863FUJIFILM Ultrasonic Endoscope EB-710USFujifilm Corporation20250—
+5K221340iNod Ultrasound Guided Biopsy Needle (UPN: M00502060), iNod Ultrasound Guidance Console…Boston Scientific Corporation20230—
+5K203128Evis Eus Endoscopic Ultrasound Center Olympus EU-ME2/Evis Eus Endoscopic Ultrasound…Olympus Medical Systems Corp.20201—
+5K183525EVIS EUS Ultrasound Bronchofibervideoscope Olympus BF-UC190FOlympus Medical Systems Corp.201921
+5K182825FUJIFILM Ultrasonic EndoscopeFujifilm Corporation20190—
+5K181763FUJIFILM Ultrasonic EndoscopeFujifilm Corporation20183—
+5K160098Single Use Aspiration Needle NA-U401SXOlympus Medical Systems Corp.201612
+5K153206Fujifilm Ultrasonic Processors SU-1 PLATINUM and SU-1Fujifilm Medical System U.S.A., Inc.20161—
+5K151315Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration NeedleBoston Scientific Corporation20153—
+5K151895Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration NeedleBoston Scientific Corporation20150—
+5K142909Flexible 19G EBUS NeedleSpiration, Inc.20157—
+5K130058Endoscopic Ultrasound Center EU-Y0008Olympus Medical Systems Corp.20134—
+5K100624Invendo C20 Colonoscopy SystemInvendo Medical Gbmh20126—
+5K093195Echotip Ultra Endobronchial High Definition Ultasound Needle, Model: Echo-HD-22-Ebus-OCook Ireland, Ltd.20108—
+5K090197EG-3870UTKPentax Medical Company200962
+5K090196EG-3670URKPentax Medical Company200921
+5K091257Medi-Globe Sonotip II Ebus-Tbna Needle SystemMedi-Globe Corporation20093—
+5K081518Ultrasound Video Bronchoscope, Model EB-1970UKPentax Medical Company20085—
+5K041397EG-3830UTPentax Precision Instrument Corp.200401
+5K031789EG-3830UT, Video Ultrasound GastroscopePentax Precision Instrument Corp.20030—
+6K260401Evis Eus Ultrasound Bronchofibervideoscope Olympus BF-UCP190F (BF-UCP190F)Olympus Medical Systems Corporation20260—
+6K243502Evis Eus Endoscopic Ultrasound Center Olympus EU-ME3 (Olympus EU-ME3)Olympus Medical Systems Corporation20250—
+6K200850Fujifilm Ultrasonic ProcessorFujifilm Corporation20200—
+6K183433FUJIFILM Ultrasonic EndoscopeFujifilm Corporation20192—
+6K180668Single Use Aspiration Needle NA-U401SX-4025/NA-U401SX-4025NOlympus Medical Systems Corp.20180—
+6K173554PENTAX Medical Video Bronchoscopes, PENTAX Medical Video Naso-Pharyngo-Laryngoscope, and…Pentax of America, Inc.20180—
+6K171207FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-MFujifilm Medical Systems U.S.A, Inc.20181—
+6K163248Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration NeedleBoston Scientific Corporation20172—
+6K161355invendoscopy E200 SystemInvendo Medical GmbH20161—
+6K161791Aer-O-Scope Colonoscope SystemGi View, Ltd.20160—
+6K160229Echotip Ultra Endobronchial High Definition Ultrasound Needle, Echotip Procore…Cook Ireland, Ltd.20167—
+6K152922ViziShot FLEXSpiration, Inc.20166—
+6K141286Aer-O-Scope Colonoscope SystemGi View, Ltd.20142—
+6K133763Sonotip Pro and Pro Flex Ebus-Tbna Needle SystemMedi-Globe Corporation20142—
+6K131946Entax Ultrasound Video Bronchoscope EB-1970UK + HI Visin PreirusPentax Medical Company201434
+6K130206Pentax EG-3670URK Ultrasound Video Gastroscope + HI Vision PreirusPentax of America, Inc.20131—
+6K130247Pentax EG-3870UTK Ultrasound Video Gastroscope + HI Vision PreirusPentax of America, Inc.201351
+6K121582Invendo C25 Colonoscopy SystemInvendo Medical Gbmh20125—
+7K250145Biopsy Port AdapterEndosound, Inc.20250—
+7K231813Ultrasonic GastrovideoscopeSonoscape Medical Corp.20240—
+7K231267ClearTipFinemedix Co., Ltd.20231—
+7K221238FUJIFILM Ultrasonic Endoscope EG-740UTFujifilm Corporation20220—
+7K221952Endoscope Model EG-580UT and Endoscope Model EG-580URFujifilm Corporation20220—
+7K214089FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M2Fujifilm Corporation20220—
+7K210476EchoTip Ultra Endoscopic Ultrasound Needle, EchoTip ProCore HD Ultrasound Biopsy Needle…Cook Ireland, Ltd.202121
+7K193517ViziShot 2 FLEXOlympus Surgical Technologies America20202Class I
+7K190669EndoticsEra Endoscopy S.R.L.20200—
+7K183516PENTAX Medical Ultrasound Video Bronchoscope EB19-J10UPentax of America, Inc.20191—
+7K183654PENTAX Medical EB-1970UK Ultrasound Video Bronchoscope + Hitachi NOBLUS and HI VISION…Pentax of America, Inc.20190—
+7K183085CoreDx™ Pulmonary Mini-ForcepsBoston Scientific Corporation20190—
+7K173085invendoscopy E210 SystemInvendo Medical GmbH20180—
+7K171956Sterile Endoscope Biopsy Sampling NeedleChangzhou Detain Medical Devices Co., Ltd.20170—
+7K162447PENTAX Medical Endoscopic Ultrasound System, EG-3270UK Upper G.I. Video Scope (Convex…Pentax of America, Inc.20174—
+7K163469ViziShot 2 FLEXOlympus Surgical Technologies America20175—
+8K261274EchoTip Ultra® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes; EchoTip…Cook Ireland, Ltd.20260—
+8K251402LIA-1 Catheter (542-1)Leadoptik, Inc.20250—
+8K250994ClearTip FNA and FNB TypesFinemedix Co., Ltd.20250—
+8K241209EchoTip AcuCore™ EUS Biopsy Needle (ECHO-BX-19)Cook Ireland, Ltd.20240—
+8K230909EchoTip® AcuCore™ Ultrasound Biopsy Needle (ECHO-BX-3-22)Cook Ireland, Ltd.20231—
+8K213060AreusTM Endobronchial Ultrasound Aspiration Needle, TridentTM Endobronchial Ultrasound…Micro-Tech (Nanjing) Co., Ltd.20221—
+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—
+8K182004PENTAX Medical Endoscopic Ultrasound SystemPentax of America, Inc.201832
+9K251478ClearTip TBNA TypeFinemedix Co., Ltd.20260—
+9K251664Single Use Aspiration Needle (NA-201SX-4021); Single Use Aspiration Needle (NA-201SX-4022)Olympus Medical Systems Corporation20250—
+9K230778EndoCorePraxis Medical, LLC20230—
+9K200090PENTAX Medical EG-J10U Endoscopic Ultrasound System - EG34-J10U Ultrasound Upper GI…Pentax of America, Inc.202022
+10K232518EndoSound Vision System; EVSEndosound, Inc.20230—