510(k) Report

Devices descending from K904667

67 later devices reach NA Needles through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K973128Olympus NA-10J-1 Aspiration NeedleOlympus America, Inc.199765—
+1K970563Olympus NA-10J-1 Aspiration NeedleOlympus America, Inc.19970—
+2K151738Single Use Aspiration Needle NA-U200HOlympus Medical Systems Corp.20153—
+2K023272Disposable Aspiration Needle NA-200HThe Olympus Optical Co.2002631
+2K991672Olympus NA-10J-KB Aspiration NeedleOlympus America, Inc.19990—
+3K181994Single Use Aspiration Needle NA-U201HOlympus Medical Systems Corp.20180—
+3K180449Single Use Aspiration Needle NA-U200HOlympus Medical Systems Corp.20181—
+3K103668BNX Fine Needle Aspiration SystemBoston Endoscopic Engineering201085
+3K100712Resound Endoscopic Ultrasound Aspiration NeedleBoston Scientific Corporation2010275
+3K050503Single Use Aspiration Needle NA-201SX-4022Olympus Medical Systems Corporation2005285
+4K252646Single-Use Fine Needle Biopsy (FNB) device (NA-U210H)Olympus Medical Systems Corp.20250—
+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—
+4K133008BNX Delivery System Pre-Loaded with 19, 22 and 25 Gauge Needle, 19, 22 or 25 Gauge…Beacon Endoscopic20137—
+4K112198Expect Endoscopic Ultrasound Aspiration NeedleBoston Scientific Corporation201116—
+4K110030Expect Endoscopic Aspiration NeedleBoston Scientific Corp2011261
+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—
+5K180668Single Use Aspiration Needle NA-U401SX-4025/NA-U401SX-4025NOlympus Medical Systems Corp.20180—
+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—
+5K142198BNX Fine Needle Aspiration SystemCovidien, LLC20145—
+5K141894Sharkcore Fine Needle Biopsy SystemCovidien, LLC ( Formerly Beacon Endoscopic Corp.)20144—
+5K133763Sonotip Pro and Pro Flex Ebus-Tbna Needle SystemMedi-Globe Corporation20142—
+5K133312Expect Slimline Endoscopic Ultrasound Aspiration NeedleBoston Scientific Corporation20148—
+5K123676Cellvizio 100 Series and Cellvizio Systems with Confocal MiniprobesMauna Kea Technologies201311—
+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
+6K183085CoreDx™ Pulmonary Mini-ForcepsBoston Scientific Corporation20190—
+6K183640Cellvizio 100 Series Confocal laser Imaging systems and their Confocal MiniprobesMauna Kea Technologies20194—
+6K180037Beacon EUS Access SystemCovidien, LLC201802
+6K172844Cellvizio 100 Series System with Confocal MiniprobesMauna Kea Technologies20176—
+6K171956Sterile Endoscope Biopsy Sampling NeedleChangzhou Detain Medical Devices Co., Ltd.20170—
+6K163469ViziShot 2 FLEXOlympus Surgical Technologies America20175—
+6K163058Expect Slimline (SL) Endoscopic Ultrasound Aspiration NeedleBoston Scientific20171—
+6K160845Acquire Endoscopic Ultrasound Fine Needle Biopsy (FNB) DeviceBoston Scientific Corporation20164—
+6K150831Cellvizio 100 Series System with Confocal MiniprobesMauna Kea Technologies20157—
+6K150891BNX Fine Needle Aspiration System and SharkCore LG Fine Needle Biopsy SystemCovidien, LLC ( Formerly Beacon Endoscopic Corp.)20153—
+6K132389Cellvizio 100 Series System and Cellvizio System with Confocal Miniprobes; Uroflex B and…Daniel & Daniel Consulting201410—
+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—
+7K251542InstaFANOnepass Medical, Ltd.20250—
+7K241275Histolog® Scanner (Hardware 2.4, Software 3.3)Samantree Medical SA20240—
+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—
+7K223616Acquire™ S Endoscopic Ultrasound Fine Needle Biopsy (FNB) DeviceBoston Scientific Corporation20220—
+7K213060AreusTM Endobronchial Ultrasound Aspiration Needle, TridentTM Endobronchial Ultrasound…Micro-Tech (Nanjing) Co., Ltd.20221—
+7K193416Cellvizio I.V.E. with Confocal MiniprobesMauna Kea Technologies20200—
+7K191144Cellvizio 100 Series System with Confocal MiniprobesMauna Kea Technologies20202—
+7K190239Single Use Aspiration NeedleOlympus Medical Systems Corp.20192—
+7K173184Expect Slimline (SL) Endoscopic Ultrasound Aspiration NeedleBoston Scientific20170—
+7K172309Endoscopic Ultrasound Aspiration NeedleMicro-Tech (Nanjing) Co., Ltd.201712
+7K152586Beacon Fine Needle Fiducial SystemCovidien, LLC20150—
+7K141358Cellvizio 100 Series with System Confocal MiniprobesMauna Kea Technologies20149—
+8K251478ClearTip TBNA TypeFinemedix Co., Ltd.20260—
+8K251664Single Use Aspiration Needle (NA-201SX-4021); Single Use Aspiration Needle (NA-201SX-4022)Olympus Medical Systems Corporation20250—
+8K243711Confocal Microprobe Imaging System (BrightP980); Confocal Microprobe Imaging System…Wuxi Hisky Medical Technologies Co., Ltd.20250—
+8K230778EndoCorePraxis Medical, LLC20230—
+8K212852Areus (TM) Adapt Endoscopic Ultrasound Aspiration Needle, Tridemt (TM) Endoscopic…Micro-Tech (Nanjing) Co., Ltd.20210—
+8K212322Cellvizio I.V.E. system with Confocal MiniprobesMauna Kea Technologies20210—
+8K160416CystoFlex UHD R-C, CelioFlex UHD 5-C, Cellvizio 100 Series (800) with Confocal MiniprobesMauna Kea Technologies20167—