510(k) Report

Devices descending from K070129

57 later devices reach Sonotip II Ultrasound Needle System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K172309Endoscopic Ultrasound Aspiration NeedleMicro-Tech (Nanjing) Co., Ltd.201712
+1K091257Medi-Globe Sonotip II Ebus-Tbna Needle SystemMedi-Globe Corporation20093—
+1K083802Sonotip II 25-Gauge Ultrasound Needle System, Models Gus-01-18-025 and Gus-01-27-025Medi-Globe Corporation20092—
+1K083330Echotip Ultra Ultrasound NeedleCook Endoscopy200949—
+2K212852Areus (TM) Adapt Endoscopic Ultrasound Aspiration Needle, Tridemt (TM) Endoscopic…Micro-Tech (Nanjing) Co., Ltd.20210—
+2K210476EchoTip Ultra Endoscopic Ultrasound Needle, EchoTip ProCore HD Ultrasound Biopsy Needle…Cook Ireland, Ltd.202121
+2K142688Echotip Procore HD Ultrasound Biopsy NeedleCook Ireland, Ltd.20149—
+2K141894Sharkcore Fine Needle Biopsy SystemCovidien, LLC ( Formerly Beacon Endoscopic Corp.)20144—
+2K133763Sonotip Pro and Pro Flex Ebus-Tbna Needle SystemMedi-Globe Corporation20142—
+2K123676Cellvizio 100 Series and Cellvizio Systems with Confocal MiniprobesMauna Kea Technologies201311—
+2K111895Echotip (R) Ultra Fiducial NeedleWilson-Cook Medical Inc./Cook Endoscopy201210—
+2K111495Cook GI Endoscopic Injection Gel Kit, Gel-S, Gel-N, Gel-H, Gel-KWilson-Cook Medical, Inc.20119—
+2K103668BNX Fine Needle Aspiration SystemBoston Endoscopic Engineering201085
+2K093195Echotip Ultra Endobronchial High Definition Ultasound Needle, Model: Echo-HD-22-Ebus-OCook Ireland, Ltd.20108—
+2K092359Echo Tip Ultra High Definition Ultrasound Access Needle, Model: Echo-HD-19ACook Ireland, Ltd.2009161
+3K260428RIVOS™ EUS Access Device (M00553900)Boston Scientific Corporation20260—
+3K241209EchoTip AcuCore™ EUS Biopsy Needle (ECHO-BX-19)Cook Ireland, Ltd.20240—
+3K231267ClearTipFinemedix Co., Ltd.20231—
+3K230909EchoTip® AcuCore™ Ultrasound Biopsy Needle (ECHO-BX-3-22)Cook Ireland, Ltd.20231—
+3K183640Cellvizio 100 Series Confocal laser Imaging systems and their Confocal MiniprobesMauna Kea Technologies20194—
+3K180363Clear-Tip EUS-FNAFinemedix Co., Ltd.20180—
+3K180037Beacon EUS Access SystemCovidien, LLC201802
+3K172844Cellvizio 100 Series System with Confocal MiniprobesMauna Kea Technologies20176—
+3K163058Expect Slimline (SL) Endoscopic Ultrasound Aspiration NeedleBoston Scientific20171—
+3K160229Echotip Ultra Endobronchial High Definition Ultrasound Needle, Echotip Procore…Cook Ireland, Ltd.20167—
+3K150831Cellvizio 100 Series System with Confocal MiniprobesMauna Kea Technologies20157—
+3K150852SIC 8000Cosmo Technologies, Ltd.20158—
+3K150891BNX Fine Needle Aspiration System and SharkCore LG Fine Needle Biopsy SystemCovidien, LLC ( Formerly Beacon Endoscopic Corp.)20153—
+3K142198BNX Fine Needle Aspiration SystemCovidien, LLC20145—
+3K141356Echo Tip Ultra Fiducial NeedleWilson-Cook Medical, Inc.20140—
+3K132389Cellvizio 100 Series System and Cellvizio System with Confocal Miniprobes; Uroflex B and…Daniel & Daniel Consulting201410—
+3K132708Biomarc Fiducial MarkerCarbon Medical Technologies, Inc.20132—
+3K133008BNX Delivery System Pre-Loaded with 19, 22 and 25 Gauge Needle, 19, 22 or 25 Gauge…Beacon Endoscopic20137—
+4K250994ClearTip FNA and FNB TypesFinemedix Co., Ltd.20250—
+4K241275Histolog® Scanner (Hardware 2.4, Software 3.3)Samantree Medical SA20240—
+4K220434Blue Eye (TS-905)The Standard Co., Ltd.20221—
+4K200071Blue Beacon Submucosal Injectable SolutionMicro-Tech (Nanjing) Co., Ltd.20200—
+4K191923EverLift Submucosal Lifting AgentGi Supply20201—
+4K193517ViziShot 2 FLEXOlympus Surgical Technologies America20202Class I
+4K193416Cellvizio I.V.E. with Confocal MiniprobesMauna Kea Technologies20200—
+4K191254EndoClotEndoclot Plus Co., Ltd.20201—
+4K191144Cellvizio 100 Series System with Confocal MiniprobesMauna Kea Technologies20202—
+4K191797BiomarC Fiducial MarkerCarbon Medical Technologies20190—
+4K180068ORISE GelBoston Scientific201811
+4K171956Sterile Endoscope Biopsy Sampling NeedleChangzhou Detain Medical Devices Co., Ltd.20170—
+4K171467BioZorb Marker GOLD / LP Marker GOLDFocal Therapeutics20170—
+4K173184Expect Slimline (SL) Endoscopic Ultrasound Aspiration NeedleBoston Scientific20170—
+4K152586Beacon Fine Needle Fiducial SystemCovidien, LLC20150—
+4K141358Cellvizio 100 Series with System Confocal MiniprobesMauna Kea Technologies20149—
+5K260997Sis Blu (Sisblu-30-01);Sis Blu (Sisblu-15-01)Endoclot Plus Co., Ltd.20260—
+5K261274EchoTip Ultra® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes; EchoTip…Cook Ireland, Ltd.20260—
+5K251402LIA-1 Catheter (542-1)Leadoptik, Inc.20250—
+5K243711Confocal Microprobe Imaging System (BrightP980); Confocal Microprobe Imaging System…Wuxi Hisky Medical Technologies Co., Ltd.20250—
+5K241591Blue EyeThe Standard Co., Ltd.20240—
+5K212322Cellvizio I.V.E. system with Confocal MiniprobesMauna Kea Technologies20210—
+5K202376EverLift Submucosal Lifting AgentGi Supply, Inc.20200—
+5K160416CystoFlex UHD R-C, CelioFlex UHD 5-C, Cellvizio 100 Series (800) with Confocal MiniprobesMauna Kea Technologies20167—