510(k) Report

Devices descending from K022595

29 later devices reach Wilson-Cook Cystotome through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K260428RIVOS™ EUS Access Device (M00553900)Boston Scientific Corporation20260—
+1K223256Optimos™ CystotomeTaewoong Medical Co., Ltd.20230—
+1K211909Cysto-Gastro-SetsG-Flex Europe Sprl20220—
+1K150692AXIOS Stent with Electrocautery Enhanced Delivery SystemBoston Scientific Corp20158—
+1K093279Navix Access DeviceXlumena201001
+1K092359Echo Tip Ultra High Definition Ultrasound Access Needle, Model: Echo-HD-19ACook Ireland, Ltd.2009161
+2K180037Beacon EUS Access SystemCovidien, LLC201802
+2K163058Expect Slimline (SL) Endoscopic Ultrasound Aspiration NeedleBoston Scientific20171—
+2K153088AXIOS Stent with Delivery System, AXIOS Stent with Electro-cautery Enhanced Delivery…Boston Scientific Corporation20156—
+2K152572AXIOS Stent and Delivery SystemBoston Scientific Corporation20157—
+2K123676Cellvizio 100 Series and Cellvizio Systems with Confocal MiniprobesMauna Kea Technologies201311—
+3K181905AXIOS Stent and Delivery System, AXIOS Stent and Electrocautery Enhanced Delivery SystemBoston Scientific Corporation201948
+3K183640Cellvizio 100 Series Confocal laser Imaging systems and their Confocal MiniprobesMauna Kea Technologies20194—
+3K172844Cellvizio 100 Series System with Confocal MiniprobesMauna Kea Technologies20176—
+3K173184Expect Slimline (SL) Endoscopic Ultrasound Aspiration NeedleBoston Scientific20170—
+3K163272AXIOS Stent and Electrocautery Enhanced Delivery SystemBoston Scientific Corporation20175—
+3K150831Cellvizio 100 Series System with Confocal MiniprobesMauna Kea Technologies20157—
+3K132389Cellvizio 100 Series System and Cellvizio System with Confocal Miniprobes; Uroflex B and…Daniel & Daniel Consulting201410—
+4K241275Histolog® Scanner (Hardware 2.4, Software 3.3)Samantree Medical SA20240—
+4K220112AXIOS Stent and Electrocautery-Enhanced Delivery SystemBoston Scientific Corporation20221—
+4K203132AXIOS Stent and Electrocautery Enhanced Delivery SystemBoston Scientific Corporation20211—
+4K193416Cellvizio I.V.E. with Confocal MiniprobesMauna Kea Technologies20200—
+4K191144Cellvizio 100 Series System with Confocal MiniprobesMauna Kea Technologies20202—
+4K192043AXIOS Stent and Electrocautery Enhanced Delivery SystemBoston Scientific Corporation20192—
+4K141358Cellvizio 100 Series with System Confocal MiniprobesMauna Kea Technologies20149—
+5K252648Niti-S SPAXUS StentTaewoong Medical Co., Ltd.20260—
+5K243711Confocal Microprobe Imaging System (BrightP980); Confocal Microprobe Imaging System…Wuxi Hisky Medical Technologies Co., Ltd.20250—
+5K212322Cellvizio I.V.E. system with Confocal MiniprobesMauna Kea Technologies20210—
+5K160416CystoFlex UHD R-C, CelioFlex UHD 5-C, Cellvizio 100 Series (800) with Confocal MiniprobesMauna Kea Technologies20167—