510(k) Report

Devices descending from K033023

9 later devices reach Intermittent Urethral Catheters through their predicates, nearest generation first.

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