510(k) Report

Devices descending from K010420

32 later devices reach Rusch MMG/O'neil Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K080881Cure Catheter Closed SystemCure Medical, LLC200810—
+1K033477Hydrophilic-Antibacterial Intermittent Catheter, Intermittent Catheter Closed System KitRochester Medical Corp.200403
+1K013483Incare Advance; Intermittent Catheter, Plus Intermittent Catheter, Plus KitHollister, Inc.200220—
+2K230400Cure Catheter Closed System; Cure Dextra Closed SystemConvatec, Inc.20231—
+2K221593Cure Ultra Male, Cure Ultra Female, Cure Ultra PlusConvatec, Inc.20222—
+2K151745FULL CARE Disposable PVC Nelaton CatheterShaoxing Fuqing Health Products Co., Ltd.20160—
+2K110653Cure CatheterCure Medical, LLC201141
+2K110862Vapro Plus Intermittent CatheterHollister Incorporated201114—
+2K090960Vapro Intermittent Catheter, Model 72062, 72082,72102, 72122, 72142, 72064, 72084…Hollister, Inc.200915—
+2K032710Closed System Intermittent Catheterization KitApogee Medical, Inc.20042—
+3K250699Cure Twist Female 8 Catheter (T8); Cure Twist Female 10 Catheter (T10); Cure Twist…Convatec20251—
+3K250891Cure Catheter Insertion Kit (K1); Cure Catheter Insertion Kit (K2); Cure Catheter…Convatec Limited20250—
+3K160877United Urologics Closed System CatheterRobling Medical, Inc.20160—
+3K141642Vapro Intermittent CatheterHollister Incorporated201413—
+3K132500Cure Catheter Female, Cure Catheter Male, Cure Catheter Coude, Cure Catheter Pediatric…Cure Medical, LLC20133—
+3K080878MTG Instant Cather (with and Without Kit), MTG Instant Cath Deluxe (with and Without Kit)Medical Technologies of Georgia, Inc.20080—
+4K260737Cure Aqua™ Ready to Use Hydrophilic Intermittent Catheter Female (CH06 - CH16); Cure…Convatec20260—
+4K260502Liv Pre-lubricated Intermittent CatheterHR Healthcare20260—
+4K181445AMSure Hydrophilic Intermittent CatheterAmsino International, Inc.20180—
+4K180824VaPro 2 Intermittent CatheterHollister Incorporated20186—
+4K163179Onli Intermittent CatheterHollister Incorporated20173—
+4K152268VAPRO PLUS POCKET Intermittent CatheterHollister Incorporated20150—
+4K143594VaPro PocketHollister Incorporated20150—
+5K220667Sleeved ICHollister Incorporated20223—
+5K211436Intermittent Catheter (Not Finalized)Hollister Incorporated202201
+5K191633Infyna ChicHollister Incorporated20191—
+5K183253ValPro 2 Plus, VaPro 2 Plus PocketHollister Incorporated20181—
+6K233524Sleeved IC 2 Family; Sleeved IC 2 SWT (Name not Finalized); Sleeved IC 2 Plus (Name not…Hollister Incorporated20242—
+6K213575Female IC (Not Finalized)Hollister Incorporated20220—
+6K193148VaPro Plus Pocket, VaPro PlusHollister Incorporated20190—
+7K253295Coude Sleeved IC; Coude Plus Sleeved ICHollister Incorporated20260—
+7K251468Sleeved IC 3 Family Sleeved IC 3 SWT (name not finalized) Sleeved IC 3 Pocket (name not…Hollister Incorporated20250—