510(k) Report

Devices descending from K901443

11 later devices reach Zimmon Papillotome through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K172665Classic Cotton Cannulatome®, CannulaTome II® Double Lumen Sphincterotome, Cotton…Wilson-Cook Medical Inc./Cook Endoscopy20184—
+1K033203Wilson-Cook Tri-Tome Select PlusWilson-Cook Medical, Inc.20036—
+2K251104SureTome™ SW Sphincterotome with DomeTipWilson-Cook Medical20250—
+2K201121SphincterotomeHangzhou AGS MedTech Co., Ltd.20212—
+2K061684Medi-Globe Rota-Cut SphincterotomeMedi-Globe Corporation20060—
+2K052051Omni SphincterotomeWilson-Cook Medical, Inc.200542
+3K232476Disposable SphincterotomeZhejiang Soudon Medical Technology Co., Ltd.20230—
+3K222421SphincterotomeHangzhou AGS MedTech Co., Ltd.20230—
+3K172288Fusion OMNI SphincterotomeWilson-Cook Medical Inc./Cook Endoscopy20183—
+4K192339TeslaTome Bipolar Sphincterotome, Tesla Bipolar Active CordWilson-Cook Medical, Inc.20201—
+5K243568Teslatome Bipolar Sphincterotome; Tesla BiCord Active CordWilson-Cook Medical, Inc.202501