510(k) Report

Devices descending from K934123

78 later devices reach Stopcock (One-Port Manifold) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K051917Diver C.E. CatheterInvatec Innovative Technologies, S.R.L.2005131
+1K050503Single Use Aspiration Needle NA-201SX-4022Olympus Medical Systems Corporation2005285
+1K023272Disposable Aspiration Needle NA-200HThe Olympus Optical Co.2002631
+2K160098Single Use Aspiration Needle NA-U401SXOlympus Medical Systems Corp.201612
+2K151738Single Use Aspiration Needle NA-U200HOlympus Medical Systems Corp.20153—
+2K151315Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration NeedleBoston Scientific Corporation20153—
+2K151895Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration NeedleBoston Scientific Corporation20150—
+2K142909Flexible 19G EBUS NeedleSpiration, Inc.20157—
+2K103668BNX Fine Needle Aspiration SystemBoston Endoscopic Engineering201085
+2K100712Resound Endoscopic Ultrasound Aspiration NeedleBoston Scientific Corporation2010275
+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—
+2K071727QXT Extraction CatheterVascular Solutions, Inc.200712—
+3K180668Single Use Aspiration Needle NA-U401SX-4025/NA-U401SX-4025NOlympus Medical Systems Corp.20180—
+3K181994Single Use Aspiration Needle NA-U201HOlympus Medical Systems Corp.20180—
+3K180449Single Use Aspiration Needle NA-U200HOlympus Medical Systems Corp.20181—
+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—
+3K133008BNX Delivery System Pre-Loaded with 19, 22 and 25 Gauge Needle, 19, 22 or 25 Gauge…Beacon Endoscopic20137—
+3K112198Expect Endoscopic Ultrasound Aspiration NeedleBoston Scientific Corporation201116—
+3K110030Expect Endoscopic Aspiration NeedleBoston Scientific Corp2011261
+3K072810Pronto Low Profile (LP) Extraction Catheter, Model 5010Vascular Solutions, Inc.200711—
+4K252646Single-Use Fine Needle Biopsy (FNB) device (NA-U210H)Olympus Medical Systems Corp.20250—
+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
+4K183085CoreDx™ Pulmonary Mini-ForcepsBoston Scientific Corporation20190—
+4K171956Sterile Endoscope Biopsy Sampling NeedleChangzhou Detain Medical Devices Co., Ltd.20170—
+4K163469ViziShot 2 FLEXOlympus Surgical Technologies America20175—
+4K142198BNX Fine Needle Aspiration SystemCovidien, LLC20145—
+4K141894Sharkcore Fine Needle Biopsy SystemCovidien, LLC ( Formerly Beacon Endoscopic Corp.)20144—
+4K133312Expect Slimline Endoscopic Ultrasound Aspiration NeedleBoston Scientific Corporation20148—
+4K123676Cellvizio 100 Series and Cellvizio Systems with Confocal MiniprobesMauna Kea Technologies201311—
+4K083784Pronto V3 Extraction Center, Model 5003, Pronto LP Extraction Catheter, Model 5010…Vascular Solutions, Inc.200910—
+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—
+5K190239Single Use Aspiration NeedleOlympus Medical Systems Corp.20192—
+5K183640Cellvizio 100 Series Confocal laser Imaging systems and their Confocal MiniprobesMauna Kea Technologies20194—
+5K180037Beacon EUS Access SystemCovidien, LLC201802
+5K172844Cellvizio 100 Series System with Confocal MiniprobesMauna Kea Technologies20176—
+5K162467Twin-Pass TorqueVascular Solutions, Inc.20172—
+5K163058Expect Slimline (SL) Endoscopic Ultrasound Aspiration NeedleBoston Scientific20171—
+5K160845Acquire Endoscopic Ultrasound Fine Needle Biopsy (FNB) DeviceBoston Scientific Corporation20164—
+5K150831Cellvizio 100 Series System with Confocal MiniprobesMauna Kea Technologies20157—
+5K150891BNX Fine Needle Aspiration System and SharkCore LG Fine Needle Biopsy SystemCovidien, LLC ( Formerly Beacon Endoscopic Corp.)20153—
+5K132389Cellvizio 100 Series System and Cellvizio System with Confocal Miniprobes; Uroflex B and…Daniel & Daniel Consulting201410—
+5K112382Terumo Aspriation CatheterTerumo Medical Corporation20110—
+5K103405Pronto V4 Extraction Catheter 5.5F; Pronto V4 Extraction Catheter 6F; Pronto V4…Vascular Solutions, Inc.201041
+5K090977Piggyback Wire ConverterVascular Solutions, Inc.20090—
+6K251478ClearTip TBNA TypeFinemedix Co., Ltd.20260—
+6K251664Single Use Aspiration Needle (NA-201SX-4021); Single Use Aspiration Needle (NA-201SX-4022)Olympus Medical Systems Corporation20250—
+6K251542InstaFANOnepass Medical, Ltd.20250—
+6K241275Histolog® Scanner (Hardware 2.4, Software 3.3)Samantree Medical SA20240—
+6K230778EndoCorePraxis Medical, LLC20230—
+6K223616Acquire™ S Endoscopic Ultrasound Fine Needle Biopsy (FNB) DeviceBoston Scientific Corporation20220—
+6K200324NHancer RxImds Operations B.V.20201—
+6K193416Cellvizio I.V.E. with Confocal MiniprobesMauna Kea Technologies20200—
+6K191144Cellvizio 100 Series System with Confocal MiniprobesMauna Kea Technologies20202—
+6K173184Expect Slimline (SL) Endoscopic Ultrasound Aspiration NeedleBoston Scientific20170—
+6K172309Endoscopic Ultrasound Aspiration NeedleMicro-Tech (Nanjing) Co., Ltd.201712
+6K161506Penumbra Aspiration SystemPenumbra, Inc.20163—
+6K152586Beacon Fine Needle Fiducial SystemCovidien, LLC20150—
+6K141358Cellvizio 100 Series with System Confocal MiniprobesMauna Kea Technologies20149—
+7K243711Confocal Microprobe Imaging System (BrightP980); Confocal Microprobe Imaging System…Wuxi Hisky Medical Technologies Co., Ltd.20250—
+7K212852Areus (TM) Adapt Endoscopic Ultrasound Aspiration Needle, Tridemt (TM) Endoscopic…Micro-Tech (Nanjing) Co., Ltd.20210—
+7K212322Cellvizio I.V.E. system with Confocal MiniprobesMauna Kea Technologies20210—
+7K210431ReCrossImds Operations B.V.20210—
+7K163618INDIGO Aspiration SystemPenumbra, Inc.20172—
+7K160416CystoFlex UHD R-C, CelioFlex UHD 5-C, Cellvizio 100 Series (800) with Confocal MiniprobesMauna Kea Technologies20167—
+8K180412Indigo Aspiration System (CAT RX and Separator 4)- Penumbra Engine Pump and CanisterPenumbra, Inc.20181—
+9K220683INDIGO Aspiration System (CAT RX Aspiration Catheter and Separator 4)Penumbra, Inc.20220—