510(k) Report

Devices descending from K013153

43 later devices reach Autotome RX Model # 4515, 4516 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K260962SphincterotomeTaewoong Medical Co., Ltd.20260—
+1K242192Disposable SphincterotomeBeijing Zksk Technology Co., Ltd.20250—
+1K232162Autotome Pro RX 39 Sphincterotome; Autotome Pro RX 44 Sphincterotome; Jagtome Pro RX 44…Boston Scientific Corporation20231—
+1K222421SphincterotomeHangzhou AGS MedTech Co., Ltd.20230—
+1K210934Sphincterotome / short-wire compatible, Sterile SphincterotomeMicro-Tech (Nanjing) Co., Ltd.20210—
+1K122203TruetomeBoston Scientific Corp20120—
+1K061684Medi-Globe Rota-Cut SphincterotomeMedi-Globe Corporation20060—
+1K033203Wilson-Cook Tri-Tome Select PlusWilson-Cook Medical, Inc.20036—
+1K022595Wilson-Cook CystotomeWilson-Cook Medical, Inc.200229—
+2K260428RIVOS™ EUS Access Device (M00553900)Boston Scientific Corporation20260—
+2K223256Optimos™ CystotomeTaewoong Medical Co., Ltd.20230—
+2K211909Cysto-Gastro-SetsG-Flex Europe Sprl20220—
+2K150692AXIOS Stent with Electrocautery Enhanced Delivery SystemBoston Scientific Corp20158—
+2K093279Navix Access DeviceXlumena201001
+2K092359Echo Tip Ultra High Definition Ultrasound Access Needle, Model: Echo-HD-19ACook Ireland, Ltd.2009161
+2K052051Omni SphincterotomeWilson-Cook Medical, Inc.200542
+3K180037Beacon EUS Access SystemCovidien, LLC201802
+3K172288Fusion OMNI SphincterotomeWilson-Cook Medical Inc./Cook Endoscopy20183—
+3K163058Expect Slimline (SL) Endoscopic Ultrasound Aspiration NeedleBoston Scientific20171—
+3K153088AXIOS Stent with Delivery System, AXIOS Stent with Electro-cautery Enhanced Delivery…Boston Scientific Corporation20156—
+3K152572AXIOS Stent and Delivery SystemBoston Scientific Corporation20157—
+3K123676Cellvizio 100 Series and Cellvizio Systems with Confocal MiniprobesMauna Kea Technologies201311—
+4K251104SureTome™ SW Sphincterotome with DomeTipWilson-Cook Medical20250—
+4K192339TeslaTome Bipolar Sphincterotome, Tesla Bipolar Active CordWilson-Cook Medical, Inc.20201—
+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—
+5K243568Teslatome Bipolar Sphincterotome; Tesla BiCord Active CordWilson-Cook Medical, Inc.202501
+5K241275Histolog® Scanner (Hardware 2.4, Software 3.3)Samantree Medical SA20240—
+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—
+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—