510(k) Report

Devices descending from K990220

59 later devices reach Modification of Gip/Medi-Globe Ultrasound Needle System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K070129Sonotip II Ultrasound Needle SystemMedi-Globe Corporation200757—
+1K051247Sonotip II Ultrasound Needle SystemMedi-Globe Corp.200558—
+2K172309Endoscopic Ultrasound Aspiration NeedleMicro-Tech (Nanjing) Co., Ltd.201712
+2K091257Medi-Globe Sonotip II Ebus-Tbna Needle SystemMedi-Globe Corporation20093—
+2K083802Sonotip II 25-Gauge Ultrasound Needle System, Models Gus-01-18-025 and Gus-01-27-025Medi-Globe Corporation20092—
+2K083330Echotip Ultra Ultrasound NeedleCook Endoscopy200949—
+3K212852Areus (TM) Adapt Endoscopic Ultrasound Aspiration Needle, Tridemt (TM) Endoscopic…Micro-Tech (Nanjing) Co., Ltd.20210—
+3K210476EchoTip Ultra Endoscopic Ultrasound Needle, EchoTip ProCore HD Ultrasound Biopsy Needle…Cook Ireland, Ltd.202121
+3K142688Echotip Procore HD Ultrasound Biopsy NeedleCook Ireland, Ltd.20149—
+3K141894Sharkcore Fine Needle Biopsy SystemCovidien, LLC ( Formerly Beacon Endoscopic Corp.)20144—
+3K133763Sonotip Pro and Pro Flex Ebus-Tbna Needle SystemMedi-Globe Corporation20142—
+3K123676Cellvizio 100 Series and Cellvizio Systems with Confocal MiniprobesMauna Kea Technologies201311—
+3K111895Echotip (R) Ultra Fiducial NeedleWilson-Cook Medical Inc./Cook Endoscopy201210—
+3K111495Cook GI Endoscopic Injection Gel Kit, Gel-S, Gel-N, Gel-H, Gel-KWilson-Cook Medical, Inc.20119—
+3K103668BNX Fine Needle Aspiration SystemBoston Endoscopic Engineering201085
+3K093195Echotip Ultra Endobronchial High Definition Ultasound Needle, Model: Echo-HD-22-Ebus-OCook Ireland, Ltd.20108—
+3K092359Echo Tip Ultra High Definition Ultrasound Access Needle, Model: Echo-HD-19ACook Ireland, Ltd.2009161
+4K260428RIVOS™ EUS Access Device (M00553900)Boston Scientific Corporation20260—
+4K241209EchoTip AcuCore™ EUS Biopsy Needle (ECHO-BX-19)Cook Ireland, Ltd.20240—
+4K231267ClearTipFinemedix Co., Ltd.20231—
+4K230909EchoTip® AcuCore™ Ultrasound Biopsy Needle (ECHO-BX-3-22)Cook Ireland, Ltd.20231—
+4K183640Cellvizio 100 Series Confocal laser Imaging systems and their Confocal MiniprobesMauna Kea Technologies20194—
+4K180363Clear-Tip EUS-FNAFinemedix Co., Ltd.20180—
+4K180037Beacon EUS Access SystemCovidien, LLC201802
+4K172844Cellvizio 100 Series System with Confocal MiniprobesMauna Kea Technologies20176—
+4K163058Expect Slimline (SL) Endoscopic Ultrasound Aspiration NeedleBoston Scientific20171—
+4K160229Echotip Ultra Endobronchial High Definition Ultrasound Needle, Echotip Procore…Cook Ireland, Ltd.20167—
+4K150831Cellvizio 100 Series System with Confocal MiniprobesMauna Kea Technologies20157—
+4K150852SIC 8000Cosmo Technologies, Ltd.20158—
+4K150891BNX Fine Needle Aspiration System and SharkCore LG Fine Needle Biopsy SystemCovidien, LLC ( Formerly Beacon Endoscopic Corp.)20153—
+4K142198BNX Fine Needle Aspiration SystemCovidien, LLC20145—
+4K141356Echo Tip Ultra Fiducial NeedleWilson-Cook Medical, Inc.20140—
+4K132389Cellvizio 100 Series System and Cellvizio System with Confocal Miniprobes; Uroflex B and…Daniel & Daniel Consulting201410—
+4K132708Biomarc Fiducial MarkerCarbon Medical Technologies, Inc.20132—
+4K133008BNX Delivery System Pre-Loaded with 19, 22 and 25 Gauge Needle, 19, 22 or 25 Gauge…Beacon Endoscopic20137—
+5K250994ClearTip FNA and FNB TypesFinemedix Co., Ltd.20250—
+5K241275Histolog® Scanner (Hardware 2.4, Software 3.3)Samantree Medical SA20240—
+5K220434Blue Eye (TS-905)The Standard Co., Ltd.20221—
+5K200071Blue Beacon Submucosal Injectable SolutionMicro-Tech (Nanjing) Co., Ltd.20200—
+5K191923EverLift Submucosal Lifting AgentGi Supply20201—
+5K193517ViziShot 2 FLEXOlympus Surgical Technologies America20202Class I
+5K193416Cellvizio I.V.E. with Confocal MiniprobesMauna Kea Technologies20200—
+5K191254EndoClotEndoclot Plus Co., Ltd.20201—
+5K191144Cellvizio 100 Series System with Confocal MiniprobesMauna Kea Technologies20202—
+5K191797BiomarC Fiducial MarkerCarbon Medical Technologies20190—
+5K180068ORISE GelBoston Scientific201811
+5K171956Sterile Endoscope Biopsy Sampling NeedleChangzhou Detain Medical Devices Co., Ltd.20170—
+5K171467BioZorb Marker GOLD / LP Marker GOLDFocal Therapeutics20170—
+5K173184Expect Slimline (SL) Endoscopic Ultrasound Aspiration NeedleBoston Scientific20170—
+5K152586Beacon Fine Needle Fiducial SystemCovidien, LLC20150—
+5K141358Cellvizio 100 Series with System Confocal MiniprobesMauna Kea Technologies20149—
+6K260997Sis Blu (Sisblu-30-01);Sis Blu (Sisblu-15-01)Endoclot Plus Co., Ltd.20260—
+6K261274EchoTip Ultra® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes; EchoTip…Cook Ireland, Ltd.20260—
+6K251402LIA-1 Catheter (542-1)Leadoptik, Inc.20250—
+6K243711Confocal Microprobe Imaging System (BrightP980); Confocal Microprobe Imaging System…Wuxi Hisky Medical Technologies Co., Ltd.20250—
+6K241591Blue EyeThe Standard Co., Ltd.20240—
+6K212322Cellvizio I.V.E. system with Confocal MiniprobesMauna Kea Technologies20210—
+6K202376EverLift Submucosal Lifting AgentGi Supply, Inc.20200—
+6K160416CystoFlex UHD R-C, CelioFlex UHD 5-C, Cellvizio 100 Series (800) with Confocal MiniprobesMauna Kea Technologies20167—