510(k) Report

Devices descending from K970278

81 later devices reach Microvasive Gold Probe through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K232633Gold Probe Bipolar Electrohemostasis Catheter; Injection Gold Probe Bipolar…Boston Scientific20230—
+1K093008Halo Ablation Catheter, Model 90-9100Barrx Medical, Incorporated201014—
+1K072383Habib EndoblateEmcision, Ltd.20075—
+1K061544Stellartech 100 Coagulation SystemStellartech Research Corp.20060—
+1K023765Stellartech Coagulation System (Models 1100C-115 & 1100C-230)Stellartech Research Corp.200242—
+1K022595Wilson-Cook CystotomeWilson-Cook Medical, Inc.200229—
+1K013139Stellartech Coagulation SystemStellartech Research Corp.200142—
+2K260428RIVOS™ EUS Access Device (M00553900)Boston Scientific Corporation20260—
+2K223256Optimos™ CystotomeTaewoong Medical Co., Ltd.20230—
+2K211909Cysto-Gastro-SetsG-Flex Europe Sprl20220—
+2K183595Aqua Medical RF Vapor SystemAqua Medical, Inc.20194—
+2K150692AXIOS Stent with Electrocautery Enhanced Delivery SystemBoston Scientific Corp20158—
+2K141357Barrx Flex Rfa Energy GeneratorCovidien Iic20141—
+2K130623Barrx Channel Rfa Endoscopic CatheterCovidien, LLC20131—
+2K112454HALO60 Ablation CatheterBarrx Medical, Inc.20124—
+2K101111Halo Ablation Catheter Model 90-9100, HALO90 Ultra Ablation Catheter Model 90-9200Barrx Medical, Inc.201011
+2K093279Navix Access DeviceXlumena201001
+2K092359Echo Tip Ultra High Definition Ultrasound Access Needle, Model: Echo-HD-19ACook Ireland, Ltd.2009161
+2K083292Habib EndohpbEmcision, Ltd.200941
+2K050831Stellartech Coagulation System 2, Models 1100C-115A and 1100C-230AStellartech Research Corp.200534—
+2K042909Stellartech Coagulation System, Models 1100C-115A & 1100C-230AStellartech Research Corp.200435—
+2K041383Stellartech Coagulation System, Models 1100C-115 and 1100C-230Stellartech Research Corp.200436—
+2K040240Stellartech Coagulation System (Models 1100C-115 & 1100C-230)Stellartech Research Corp.200437—
+2K032721Modification to: Stellartech Coagulation System (Models 1100C-115 & 1100C-230)Stellartech Research Corp.200338—
+2K032452Modification to: Stellartech Coagulation System, Models 1100C-115 & 100C-230Stellartech Research Corp.200339—
+2K032062Stellartech Coagulation System, Models (1100C-115 & 1100C-230)Stellartech Research Corp.200341—
+3K251226Aqua Medical RF Vapor Ablation SystemAqua Medical, Inc.20250—
+3K241271Aqua Medical RF Vapor Ablation SystemAqua Medical, Inc.20241—
+3K213627RF Vapor SystemAqua Medical, Inc.20212—
+3K211282Aqua Medical RF Vapor SystemAqua Medical, Inc.20213—
+3K180037Beacon EUS Access SystemCovidien, LLC201802
+3K180165Habib EndoHPBEmcision, Ltd.20183—
+3K173559Barrx SB RFA Endoscopic CatheterCovidien, LLC20180—
+3K163058Expect Slimline (SL) Endoscopic Ultrasound Aspiration NeedleBoston Scientific20171—
+3K162802Barrx Anorectal RFA WandCovidien, LLC20170—
+3K160360Barrx FLEX RFA Energy GeneratorCovidien, LLC20160—
+3K153088AXIOS Stent with Delivery System, AXIOS Stent with Electro-cautery Enhanced Delivery…Boston Scientific Corporation20156—
+3K152572AXIOS Stent and Delivery SystemBoston Scientific Corporation20157—
+3K150251Barrx Anorectal RFA WandCovidien, LLC20151—
+3K123676Cellvizio 100 Series and Cellvizio Systems with Confocal MiniprobesMauna Kea Technologies201311—
+3K120431HALO90 Ultra Ablation CatheterBarrx Medical, Inc.20120—
+3K082202HALO360 Energy Generator, Models 1100C-115B and 1100C-230BBarrx Medical, Incorporated20080—
+3K062441Barrx Halo Coagulation System; Generator, Model 90-9000; Output Cable, Model 90-9010…Barrx Medical, Incorporated20063—
+3K062225Halo Coagulation CatheterBarrx Medical, Incorporated200620—
+3K060169Barrx Halo Coagulation System, Barrx Halo Coagulation Generator, Barrx Coagulation…Barrx Medical, Incorporated200629—
+4K231533Habib EndoHPBBoston Scientific Corporation20230—
+4K181758ELRA ElectrodeStarmed Co., Ltd.20191—
+4K181905AXIOS Stent and Delivery System, AXIOS Stent and Electrocautery Enhanced Delivery SystemBoston Scientific Corporation201948
+4K183640Cellvizio 100 Series Confocal laser Imaging systems and their Confocal MiniprobesMauna Kea Technologies20194—
+4K172844Cellvizio 100 Series System with Confocal MiniprobesMauna Kea Technologies20176—
+4K173184Expect Slimline (SL) Endoscopic Ultrasound Aspiration NeedleBoston Scientific20170—
+4K163272AXIOS Stent and Electrocautery Enhanced Delivery SystemBoston Scientific Corporation20175—
+4K150831Cellvizio 100 Series System with Confocal MiniprobesMauna Kea Technologies20157—
+4K132389Cellvizio 100 Series System and Cellvizio System with Confocal Miniprobes; Uroflex B and…Daniel & Daniel Consulting201410—
+4K092487Haloflex Energy Generator, Models 1190A-115A and 1190A-230ABarrx Medical, Incorporated200921
+4K080557Barrx Models HALO360 and HALO360+ Coagulation CathetersBarrx Medical, Incorporated20080—
+4K071543HALO360' Coagulation CatheterBarrx Medical, Incorporated200719—
+4K062723HALO90 Coagulation CatheterBarrx Medical, Incorporated200626—
+5K241275Histolog® Scanner (Hardware 2.4, Software 3.3)Samantree Medical SA20240—
+5K233113ELRA Electrode (7-2B11S, 7-2B11L, 7-2B22S, 7-2B22L, 7-4B18S, 7-4B18L, 7-4B33S, 7-4B33L)Starmed Co., Ltd.20230—
+5K220112AXIOS Stent and Electrocautery-Enhanced Delivery SystemBoston Scientific Corporation20221—
+5K203132AXIOS Stent and Electrocautery Enhanced Delivery SystemBoston Scientific Corporation20211—
+5K193416Cellvizio I.V.E. with Confocal MiniprobesMauna Kea Technologies20200—
+5K191144Cellvizio 100 Series System with Confocal MiniprobesMauna Kea Technologies20202—
+5K192043AXIOS Stent and Electrocautery Enhanced Delivery SystemBoston Scientific Corporation20192—
+5K141358Cellvizio 100 Series with System Confocal MiniprobesMauna Kea Technologies20149—
+5K093855Halo 360 & Sizing Balloon, Model 3441CBarrx Medical, Incorporated20103—
+5K083737Halo Ablation CatheterBarrx Medical, Incorporated200922—
+5K083711Modification to: Halo Coagulation Catheter, Models 32041-18, 32041-20, 32041-22…Barrx Medical, Incorporated200917—
+6K252648Niti-S SPAXUS StentTaewoong Medical Co., Ltd.20260—
+6K243711Confocal Microprobe Imaging System (BrightP980); Confocal Microprobe Imaging System…Wuxi Hisky Medical Technologies Co., Ltd.20250—
+6K212322Cellvizio I.V.E. system with Confocal MiniprobesMauna Kea Technologies20210—
+6K160416CystoFlex UHD R-C, CelioFlex UHD 5-C, Cellvizio 100 Series (800) with Confocal MiniprobesMauna Kea Technologies20167—
+6K152329Coldplay Cryoballoon; Focal Ablation System, Full Ablation System; Swipe Ablation SystemC2 Therapeutics, Inc.201661
+6K142364Barrx RFA Self Sizing Balloon CatheterCovidien, LLC20140—
+7K163684C2 CryoBalloon Ablation SystemC2 Therapeutics, Inc.201844
+7K161202C2 Cryoballoon Ablation SystemC2 Therapeutics, Inc.201751
+8K190194C2 CryoBalloon Catheter (Pear), C2 CryoBalloon (Standard), C2 CryoBalloon Controller, C2…Pentax Medical, A Division of Pentax of America, Inc.20193—
+9K203024C2 CryoBalloon Catheter (Pear), C2 CryoBalloon Catheter (Standard), C2 CryoBalloon…Pentax of America, Inc.20202—
+10K212814C2 CryoBalloon Ablation SystemPentax of America, Inc.20211—
+11K240457C2 CryoBalloon Ablation System (C2 CryoBalloon Ablation System)Pentax of America, Inc.20240—