510(k) Report

Devices descending from K964955

4 later devices reach Flexfinder Guidewire (Regular Shaft/Stiff Shaft) Marked Ink Bands… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K023603Endo-Glide GuidewireEndo-Therapeutics, Inc.20032—
+1K012556Reprocessed GuidewiresSterilmed, Inc.200201
+2K051068Zutron Colonoscope Stiffening DeviceZutron Medical20051—
+3K251204FUJIFILM Stiffening Wire Device (SW-2000)FUJIFILM Healthcare Americas Corporation20250—