510(k) Report

Devices descending from K080881

10 later devices reach Cure Catheter Closed System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K230400Cure Catheter Closed System; Cure Dextra Closed SystemConvatec, Inc.20231—
+1K221593Cure Ultra Male, Cure Ultra Female, Cure Ultra PlusConvatec, Inc.20222—
+1K151745FULL CARE Disposable PVC Nelaton CatheterShaoxing Fuqing Health Products Co., Ltd.20160—
+1K110653Cure CatheterCure Medical, LLC201141
+2K250699Cure Twist Female 8 Catheter (T8); Cure Twist Female 10 Catheter (T10); Cure Twist…Convatec20251—
+2K250891Cure Catheter Insertion Kit (K1); Cure Catheter Insertion Kit (K2); Cure Catheter…Convatec Limited20250—
+2K132500Cure Catheter Female, Cure Catheter Male, Cure Catheter Coude, Cure Catheter Pediatric…Cure Medical, LLC20133—
+3K260737Cure Aqua™ Ready to Use Hydrophilic Intermittent Catheter Female (CH06 - CH16); Cure…Convatec20260—
+3K260502Liv Pre-lubricated Intermittent CatheterHR Healthcare20260—
+3K181445AMSure Hydrophilic Intermittent CatheterAmsino International, Inc.20180—