510(k) Report

Devices descending from K091417

8 later devices reach Single Use Guidewire, Models G-240-2527S, G-240-2545S, G-240-2527A… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K122505Single Use Preloaded Sphincterotome VOlympus Medical Systems Corp.20137—
+2K150142Single Use Balloon Dilator V (with Knife)Olympus Medical Systems Corp.20151—
+2K141991Single Use Preloaded Sphincterotome V (Distal Wireguided); Single Use SPOlympus Medical Systems Copr.201543
+3K250945Single Use Preloaded Sphincterotome V (Distal Wire Guided) (KD-VC600 Series); Single Use…Olympus Medical Systems Corp.2025016
+3K192339TeslaTome Bipolar Sphincterotome, Tesla Bipolar Active CordWilson-Cook Medical, Inc.20201—
+3K193039Single Use Balloon Dilator V (with knife)Olympus Medical Systems Corp.20190—
+3K160241Single Use Sphincterotome V (Distal Wireguided) KD-VC412Q-0215Olympus Medical Systems Corp.201601
+4K243568Teslatome Bipolar Sphincterotome; Tesla BiCord Active CordWilson-Cook Medical, Inc.202501