510(k) Report

Devices descending from K113424

3 later devices reach Lofric Single Use Urinary Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K122078Lofric Primo, Lofric Hydro-KitAstra Tech, Inc.201223
+2K250659LoFric OrigoWellspect AB20251—
+3K261658LoFric Origo Pro CoudéWellspect AB20260—