510(k) Report

Devices descending from K201121

2 later devices reach Sphincterotome through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K232476Disposable SphincterotomeZhejiang Soudon Medical Technology Co., Ltd.20230—
+1K222421SphincterotomeHangzhou AGS MedTech Co., Ltd.20230—