510(k) Report

Devices descending from K003873

27 later devices reach Mentor Self-Cath Closed System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K070939Self-Cath CS Closed Urinary Catheterization SystemColoplast Manufacturing Us, LLC20070—
+1K052440Mentor Self-Cath Hydrogel Intermittent CatheterMentor Corporation20053—
+1K050008Mentor Self-Cath Hydrogel Intermittent CatheterMentor Corp.20050—
+1K033477Hydrophilic-Antibacterial Intermittent Catheter, Intermittent Catheter Closed System KitRochester Medical Corp.200403
+1K032710Closed System Intermittent Catheterization KitApogee Medical, Inc.20042—
+1K013483Incare Advance; Intermittent Catheter, Plus Intermittent Catheter, Plus KitHollister, Inc.200220—
+2K160877United Urologics Closed System CatheterRobling Medical, Inc.20160—
+2K110862Vapro Plus Intermittent CatheterHollister Incorporated201114—
+2K090960Vapro Intermittent Catheter, Model 72062, 72082,72102, 72122, 72142, 72064, 72084…Hollister, Inc.200915—
+2K080878MTG Instant Cather (with and Without Kit), MTG Instant Cath Deluxe (with and Without Kit)Medical Technologies of Georgia, Inc.20080—
+2K071496Icath, SterilesureColorado Catheter Company, Inc.20072—
+3K141642Vapro Intermittent CatheterHollister Incorporated201413—
+3K103043Colorado Catheter Sterilesure - New Name Perfic CathAdapta Medical, Inc.20111—
+4K180824VaPro 2 Intermittent CatheterHollister Incorporated20186—
+4K163179Onli Intermittent CatheterHollister Incorporated20173—
+4K161445PerfIC Cath Gel S, PerfIC Cath Gel C, PerfIC Cath Hydro S, PerfIC Cath Hydro CAdapta Medical, Inc.20160—
+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—