510(k) Report

Devices descending from K141642

13 later devices reach Vapro Intermittent Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K180824VaPro 2 Intermittent CatheterHollister Incorporated20186—
+1K163179Onli Intermittent CatheterHollister Incorporated20173—
+1K152268VAPRO PLUS POCKET Intermittent CatheterHollister Incorporated20150—
+1K143594VaPro PocketHollister Incorporated20150—
+2K220667Sleeved ICHollister Incorporated20223—
+2K211436Intermittent Catheter (Not Finalized)Hollister Incorporated202201
+2K191633Infyna ChicHollister Incorporated20191—
+2K183253ValPro 2 Plus, VaPro 2 Plus PocketHollister Incorporated20181—
+3K233524Sleeved IC 2 Family; Sleeved IC 2 SWT (Name not Finalized); Sleeved IC 2 Plus (Name not…Hollister Incorporated20242—
+3K213575Female IC (Not Finalized)Hollister Incorporated20220—
+3K193148VaPro Plus Pocket, VaPro PlusHollister Incorporated20190—
+4K253295Coude Sleeved IC; Coude Plus Sleeved ICHollister Incorporated20260—
+4K251468Sleeved IC 3 Family Sleeved IC 3 SWT (name not finalized) Sleeved IC 3 Pocket (name not…Hollister Incorporated20250—