510(k) Report

Devices descending from K172288

3 later devices reach Fusion OMNI Sphincterotome through their predicates, nearest generation first.

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