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Hollister Incorporated FDA Approvals

0 new drug approvals and 6 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product
Coude Sleeved IC; Coude Plus Sleeved IC510(k)May 18, 2026Gastroenterology, Urology
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)510(k)Oct 3, 2025Gastroenterology, Urology
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)510(k)May 3, 2024Gastroenterology, Urology
Sleeved IC510(k)Dec 8, 2022Gastroenterology, Urology
Female IC (Not Finalized)510(k)Sep 13, 2022Gastroenterology, Urology
Intermittent Catheter (Not Finalized)510(k)Jan 27, 2022Gastroenterology, Urology

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