Hollister Incorporated - FDA 510(k) Cleared Devices

Hollister Incorporated, specializes in ostomy, continence, and critical care products with a manufacturing facility in Libertyville, US. The company serves patients and healthcare professionals globally across multiple therapeutic areas.

Hollister has received 14 FDA 510(k) clearances from 14 total submissions since 2011. The company's regulatory focus centers on Gastroenterology & Urology devices, with the most recent clearance in 2025. This demonstrates sustained innovation and active market engagement in continence care solutions.

Recent cleared devices include intermittent catheter systems such as the Sleeved IC family, VaPro and VaPro Plus lines, Infyna Chic, and Onli catheters. These products reflect the company's emphasis on patient comfort, discretion, and clinical safety in continence management.

Explore the complete list of device names, product codes, and clearance dates in the 510(k) database to review Hollister's full regulatory history and cleared device portfolio.