Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Hollister Incorporated

FDA 510(k) & PMA Approved Devices — 11 products

Total Devices11
Categories2
Latest FDA decision2026-05-18
TypeNumberDevice NameCodeDateActions
510(k) K253295 Coude Sleeved IC; Coude Plus Sleeved ICEZD2026-05-18 View
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)EZD2025-10-03 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)EZD2024-05-03 View
510(k) K220667 Sleeved ICEZD2022-12-08 View
510(k) K213575 Female IC (Not Finalized)EZD2022-09-13 View
510(k) K211436 Intermittent Catheter (Not Finalized)GBM2022-01-27 View
510(k) K193148 VaPro Plus Pocket, VaPro PlusGBM2019-12-13 View
510(k) K191633 Infyna ChicGBM2019-07-19 View
510(k) K183253 ValPro 2 Plus, VaPro 2 Plus PocketGBM2018-12-18 View
510(k) K180824 VaPro 2 Intermittent CatheterGBM2018-06-22 View
510(k) K163179 Onli Intermittent CatheterGBM2017-01-26 View

Related Clinical Trials