510(k) Report

Devices descending from K964575

10 later devices reach Sympacath Hydrogel Coated Foley through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K033023Intermittent Urethral CathetersRusch Intl.20039—
+2K111405Bever Unocated / Coated, Paediatric / Male / Female Nelaton-Tip / Tiemann-Tip…Hangzhou Bever Medical Devices Co., Ltd.20122—
+2K072539Cure CatheterCure Medical, LLC200751
+3K161445PerfIC Cath Gel S, PerfIC Cath Gel C, PerfIC Cath Hydro S, PerfIC Cath Hydro CAdapta Medical, Inc.20160—
+3K151745FULL CARE Disposable PVC Nelaton CatheterShaoxing Fuqing Health Products Co., Ltd.20160—
+3K142767ThinkMed Intermittent Catheter with/without Hydrophilic CoatingThinkmed Medical Technology Co., Ltd.20150—
+3K132500Cure Catheter Female, Cure Catheter Male, Cure Catheter Coude, Cure Catheter Pediatric…Cure Medical, LLC20133—
+3K110653Cure CatheterCure Medical, LLC201141
+4K260737Cure Aqua™ Ready to Use Hydrophilic Intermittent Catheter Female (CH06 - CH16); Cure…Convatec20260—
+4K181445AMSure Hydrophilic Intermittent CatheterAmsino International, Inc.20180—