Urolution Medical said it has received FDA 510(k) clearance for its OpenFlo Urinary Catheter
Cleared for urinary tract drainage in adult patients for indwell periods of up to 30 days, the device incorporates a patented architecture that re-engineers key mechanical features of the conventional Foley catheter, including its distal tip and drainage configuration.
“FDA clearance represents the culmination of years of work to rethink one of the most widely used medical devices in patient care,” said Weihao Qu, co-founder and president of Urolution Medical, in a statement. “OpenFlo was built around a different approach to catheter architecture. With clearance achieved, our focus now shifts to clinical validation, strategic partnerships, and bringing the technology toward commercial use.”
OpenFlo features a manufacturing approach that uses established silicone catheter production methods, with costs comparable to those of conventional all-silicone Foley catheters. This manufacturing profile supports a scalable path toward commercialization without substantial manufacturing cost increases.
Urolution Medical is now preparing for clinical studies designed to evaluate comparative catheter performance and patient outcomes while advancing manufacturing and commercialization activities. The company is also pursuing strategic partnerships, additional capital, and commercial relationships with established healthcare organizations as it moves OpenFlo toward broader market introduction.
