510(k) Report

Devices descending from K060243

11 later devices reach Olympus Guide Sheath, Model XBO1-836-13 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K254037LungFlow Airway CatheterFree Flow Medical, Inc.20260—
+1K192164Single Use Guide Sheath Kit K-401, K-402, & Single Use Guiding Device CC-220DROlympus Medical Systems Corp.20201—
+1K172955LungVision ToolBodyvision Medical, Ltd.20181—
+1K131234Lungpoint Tools (Lungpoint Sheath, Lungpoint Dilation Balloon)Broncus Medical, Inc.20135—
+2K232601BroncTru™ Transbronchial Access ToolBroncus Medical, Inc.20240—
+2K221302Recon Steerable SheathSerpex Medical, Inc.20220—
+2K212667Single Use Guide Sheath Kit-401, K-402Olympus Medical Systems Corp.20210—
+2K200702EasyPath RF Introducer SheathBroncus Medical, Inc.20210—
+2K142934CrossCountry Transbronchial Access Tool straight, CrossCountry Transbronchial Access…Covidien20152—
+2K150280PulmoVia Working ChannelSanovas, Inc.20150—
+3K260565SmartClip Delivery Catheter (ADR-1715)Elucent Medical20260—