510(k) Report

Devices descending from K172665

4 later devices reach Classic Cotton Cannulatome®, CannulaTome II® Double Lumen Sphincterotome… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K251104SureTome™ SW Sphincterotome with DomeTipWilson-Cook Medical20250—
+1K201121SphincterotomeHangzhou AGS MedTech Co., Ltd.20212—
+2K232476Disposable SphincterotomeZhejiang Soudon Medical Technology Co., Ltd.20230—
+2K222421SphincterotomeHangzhou AGS MedTech Co., Ltd.20230—