Cathbuddy, Inc. - FDA 510(k) Cleared Devices

Cathbuddy, Inc. develops innovative catheterization systems designed for patients requiring intermittent catheterization. The company, with a manufacturing facility in Syracuse, US, focuses on improving user experience and reducing infection risk through reusable catheter technology.

Cathbuddy has submitted 1 FDA 510(k) application in the Gastroenterology & Urology category and received 0 clearances. The company's lead product, the Aurie System, received FDA marketing authorization through the Class II De Novo pathway and is designed for patients with spinal cord injuries and other conditions requiring long-term catheterization.

The Aurie System features a reusable no-touch catheter engineered for up to 100 uses, paired with a portable Personal Disinfector for automated cleaning and disinfection. Key design elements include polished eyelets to minimize urethral trauma, an articulating support handle for stability, and materials free from phthalates and BPA. The system is intended to reduce the burden and cost of single-use catheter dependency.

For detailed information on device names, product codes, and regulatory clearance dates, explore the full 510(k) database record.