510(k) Report

Devices descending from K052051

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K172288Fusion OMNI SphincterotomeWilson-Cook Medical Inc./Cook Endoscopy20183—
+2K251104SureTome™ SW Sphincterotome with DomeTipWilson-Cook Medical20250—
+2K192339TeslaTome Bipolar Sphincterotome, Tesla Bipolar Active CordWilson-Cook Medical, Inc.20201—
+3K243568Teslatome Bipolar Sphincterotome; Tesla BiCord Active CordWilson-Cook Medical, Inc.202501