510(k) Report

Devices descending from K970053

57 later devices reach Ultratomerx through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K073046Ethicon Endo Surgery Articulating Needle Knife, Model 2504Ethicon Endo-Surgery, Inc.20086—
+1K013153Autotome RX Model # 4515, 4516Boston Scientific Corp20014332
+1K010610Rapid Exchange Biopsy Cap and Locking Device #4526 & 4527Boston Scientific Corp20016—
+2K260962SphincterotomeTaewoong Medical Co., Ltd.20260—
+2K242192Disposable SphincterotomeBeijing Zksk Technology Co., Ltd.20250—
+2K232162Autotome Pro RX 39 Sphincterotome; Autotome Pro RX 44 Sphincterotome; Jagtome Pro RX 44…Boston Scientific Corporation20231—
+2K222421SphincterotomeHangzhou AGS MedTech Co., Ltd.20230—
+2K210934Sphincterotome / short-wire compatible, Sterile SphincterotomeMicro-Tech (Nanjing) Co., Ltd.20210—
+2K210353AutoCap RXBoston Scientific Corporation20210—
+2K122203TruetomeBoston Scientific Corp20120—
+2K082955Ethicon Endo-Surgery Articulating Hook Knife, Model IN4505Ethicon Endo-Surgery, Inc.20092—
+2K082114Electrocautery Dilation Balloon, Models: Edb-0018-00, Edb-0020-00, Edb-0022-00Apollo Endosurgery, Inc.20082—
+2K061684Medi-Globe Rota-Cut SphincterotomeMedi-Globe Corporation20060—
+2K040137Wilson-Cook Usw Cap and Wire LockWilson-Cook Medical, Inc.20044—
+2K033203Wilson-Cook Tri-Tome Select PlusWilson-Cook Medical, Inc.20036—
+2K022595Wilson-Cook CystotomeWilson-Cook Medical, Inc.200229—
+3K260428RIVOS™ EUS Access Device (M00553900)Boston Scientific Corporation20260—
+3K223256Optimos™ CystotomeTaewoong Medical Co., Ltd.20230—
+3K211909Cysto-Gastro-SetsG-Flex Europe Sprl20220—
+3K213483SnapLoc Wire LockWilson Cook Medical20220—
+3K220247Guidewire Locking DeviceMicro-Tech (Nanjing) Co., Ltd.20220—
+3K202237Locking deviceHangzhou AGS MedTech Co., Ltd.20200—
+3K190164CleverLock Guidewire Locking Device and Biopsy CapOlympus Surgical Technologies America20190—
+3K150692AXIOS Stent with Electrocautery Enhanced Delivery SystemBoston Scientific Corp20158—
+3K103155Sumo Access and Tissue Resection SystemApollo Endosurgery, Inc.20110—
+3K093279Navix Access DeviceXlumena201001
+3K091824Ethicon Endo-Surgery Rotating Endoscopic Scissors, Model IN2507Ethicon Endo-Surgery, Inc.20090—
+3K092359Echo Tip Ultra High Definition Ultrasound Access Needle, Model: Echo-HD-19ACook Ireland, Ltd.2009161
+3K091290Ethicon Endo-Surgery Rotating Hook Knife, Model IN2508Ethicon Endo-Surgery, Inc.20090—
+3K052051Omni SphincterotomeWilson-Cook Medical, Inc.200542
+4K180037Beacon EUS Access SystemCovidien, LLC201802
+4K172288Fusion OMNI SphincterotomeWilson-Cook Medical Inc./Cook Endoscopy20183—
+4K163058Expect Slimline (SL) Endoscopic Ultrasound Aspiration NeedleBoston Scientific20171—
+4K153088AXIOS Stent with Delivery System, AXIOS Stent with Electro-cautery Enhanced Delivery…Boston Scientific Corporation20156—
+4K152572AXIOS Stent and Delivery SystemBoston Scientific Corporation20157—
+4K123676Cellvizio 100 Series and Cellvizio Systems with Confocal MiniprobesMauna Kea Technologies201311—
+5K251104SureTome™ SW Sphincterotome with DomeTipWilson-Cook Medical20250—
+5K192339TeslaTome Bipolar Sphincterotome, Tesla Bipolar Active CordWilson-Cook Medical, Inc.20201—
+5K181905AXIOS Stent and Delivery System, AXIOS Stent and Electrocautery Enhanced Delivery SystemBoston Scientific Corporation201948
+5K183640Cellvizio 100 Series Confocal laser Imaging systems and their Confocal MiniprobesMauna Kea Technologies20194—
+5K172844Cellvizio 100 Series System with Confocal MiniprobesMauna Kea Technologies20176—
+5K173184Expect Slimline (SL) Endoscopic Ultrasound Aspiration NeedleBoston Scientific20170—
+5K163272AXIOS Stent and Electrocautery Enhanced Delivery SystemBoston Scientific Corporation20175—
+5K150831Cellvizio 100 Series System with Confocal MiniprobesMauna Kea Technologies20157—
+5K132389Cellvizio 100 Series System and Cellvizio System with Confocal Miniprobes; Uroflex B and…Daniel & Daniel Consulting201410—
+6K243568Teslatome Bipolar Sphincterotome; Tesla BiCord Active CordWilson-Cook Medical, Inc.202501
+6K241275Histolog® Scanner (Hardware 2.4, Software 3.3)Samantree Medical SA20240—
+6K220112AXIOS Stent and Electrocautery-Enhanced Delivery SystemBoston Scientific Corporation20221—
+6K203132AXIOS Stent and Electrocautery Enhanced Delivery SystemBoston Scientific Corporation20211—
+6K193416Cellvizio I.V.E. with Confocal MiniprobesMauna Kea Technologies20200—
+6K191144Cellvizio 100 Series System with Confocal MiniprobesMauna Kea Technologies20202—
+6K192043AXIOS Stent and Electrocautery Enhanced Delivery SystemBoston Scientific Corporation20192—
+6K141358Cellvizio 100 Series with System Confocal MiniprobesMauna Kea Technologies20149—
+7K252648Niti-S SPAXUS StentTaewoong Medical Co., Ltd.20260—
+7K243711Confocal Microprobe Imaging System (BrightP980); Confocal Microprobe Imaging System…Wuxi Hisky Medical Technologies Co., Ltd.20250—
+7K212322Cellvizio I.V.E. system with Confocal MiniprobesMauna Kea Technologies20210—
+7K160416CystoFlex UHD R-C, CelioFlex UHD 5-C, Cellvizio 100 Series (800) with Confocal MiniprobesMauna Kea Technologies20167—