510(k) Report

Devices descending from K021179

10 later devices reach Disposable Guidewire, Models G-205-3545S & G-205-3545A through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K091417Single Use Guidewire, Models G-240-2527S, G-240-2545S, G-240-2527A, G-240-2545A…Terumo Corp.20098—
+1K072354Guidewire, Model G-V220-3527S and OthersAccellent, Inc.20070—
+2K122505Single Use Preloaded Sphincterotome VOlympus Medical Systems Corp.20137—
+3K150142Single Use Balloon Dilator V (with Knife)Olympus Medical Systems Corp.20151—
+3K141991Single Use Preloaded Sphincterotome V (Distal Wireguided); Single Use SPOlympus Medical Systems Copr.201543
+4K250945Single Use Preloaded Sphincterotome V (Distal Wire Guided) (KD-VC600 Series); Single Use…Olympus Medical Systems Corp.2025016
+4K192339TeslaTome Bipolar Sphincterotome, Tesla Bipolar Active CordWilson-Cook Medical, Inc.20201—
+4K193039Single Use Balloon Dilator V (with knife)Olympus Medical Systems Corp.20190—
+4K160241Single Use Sphincterotome V (Distal Wireguided) KD-VC412Q-0215Olympus Medical Systems Corp.201601
+5K243568Teslatome Bipolar Sphincterotome; Tesla BiCord Active CordWilson-Cook Medical, Inc.202501