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Hollister Incorporated

FDA 510(k) & PMA Approved Devices — 10 products

Total Devices10
Categories2
Latest Approval2025-10-03
TypeNumberDevice NameCodeDate
510(k) K251468 Sleeved IC 3 Family Sleeved IC 3 SWT (name not finalized) Sleeved IC 3 Pocket (name not finalized) Sleeved IC 3 Plus (name not finalized) Sleeved IC 3 Plus Pocket (name not finalized) (N/A) EZD 2025-10-03 View
510(k) K233524 Sleeved IC 2 Family; Sleeved IC 2 SWT (Name not Finalized); Sleeved IC 2 Plus (Name not Finalized); Sleeved IC 2 Pocket (Name not Finalized); Sleeved IC 2 Plus Pocket (Name not Finalized) EZD 2024-05-03 View
510(k) K220667 Sleeved IC EZD 2022-12-08 View
510(k) K213575 Female IC (Not Finalized) EZD 2022-09-13 View
510(k) K211436 Intermittent Catheter (Not Finalized) GBM 2022-01-27 View
510(k) K193148 VaPro Plus Pocket, VaPro Plus GBM 2019-12-13 View
510(k) K191633 Infyna Chic GBM 2019-07-19 View
510(k) K183253 ValPro 2 Plus, VaPro 2 Plus Pocket GBM 2018-12-18 View
510(k) K180824 VaPro 2 Intermittent Catheter GBM 2018-06-22 View
510(k) K163179 Onli Intermittent Catheter GBM 2017-01-26 View