510(k) Report

Devices descending from K100878

13 later devices reach Self Cath Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K221401Self-Cath and Self-Cath PlusColoplast20221—
+1K172924GentleCath Intermittent Urinary CatheterConvatec Limited20170—
+1K142575Bard RiteCath Intermittent Urinary CatheterC.R. Bard, Inc.20142—
+1K140945Compactcath Intermittent Urinary CatheterCompactcath, Inc.20142—
+1K140953Gentlecath Male Coude Olive Tip Intermittent Urinary CatheterConvatec, Ltd.20141—
+1K133470Bard Ritecath Intermittent CatheterC.R. Bard, Inc.20143—
+1K132619Classic Intermittent CatheterFlexicare Medical, Ltd.20130—
+1K103086Dynarex Intermittent Catheters, Male, Female, PediatricDynarex Corporation20110—
+2K223821Self-Cath Closed SystemColoplast20230—
+2K212430BONREE Nelaton CatheterBonree Medical Co., Ltd.20220—
+2K180738COMPACTCATH Lubricated Intermittent UrinaryCatheter and OneCath Intermittent Urinary…Compactcath, Inc.20180—
+2K170233Diposable Urinary Catheter (PVC Urinary Catheter, Silicone Urinary Catheter, Latex…Zhanjiang Star Enterprise Co., Ltd.20170—
+2K160858CompactCath Intermittent Urinary CatheterCompactcath, Inc.20161—