Urolution Medical Receives FDA 510(k) Clearance for OpenFlo® Catheter

MAPLE GROVE, Minn.--(BUSINESS WIRE)--Urolution Medical, Inc. announced today that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its OpenFlo® Urinary Catheter, marking a major milestone as the company advances toward clinical evaluation and commercialization.

Cleared for urinary tract drainage in adult patients for indwell periods of up to 30 days, OpenFlo® 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. “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.”

John D. Adams Jr., MD, Chief Medical Officer of Urolution Medical, added, “OpenFlo® represents an opportunity to evaluate whether a differentiated catheter design can translate into meaningful improvements in clinical performance. FDA clearance allows us to take that next step through rigorous clinical evaluation.”

OpenFlo® was engineered with commercial scalability as a core design consideration. Its manufacturing approach leverages 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.

About Urolution Medical, Inc.

Urolution Medical is a Minnesota-based medical device company developing differentiated technologies intended to advance urological care.

Forward-Looking Statements

This release contains forward-looking statements regarding clinical studies, commercialization, manufacturing, financing, strategic partnerships, and potential clinical and economic outcomes. Actual results may differ materially from current expectations due to risks and uncertainties.