LI Medical Corporation, a medical device manufacturer specializing in women’s health and reproductive care, is proud to announce that its Hysterosalpingography (HSG) Catheter has received U.S. FDA 510(k) clearance under submission number K252260. This clearance confirms the device’s substantial equivalence to predicate devices and authorizes its commercial distribution in the United States.

The FDA clearance marks a major milestone in the company’s regulatory and global expansion strategy. The newly cleared HSG Catheter is designed to support diagnostic imaging of the uterine cavity and fallopian tube patency, enabling clinicians to perform hysterosalpingography procedures safely, efficiently, and comfortably for patients.

This achievement is further supported by LI Medical’s ISO 13485 certification, demonstrating the company’s commitment to maintaining a robust Quality Management System and meeting international standards for the design, manufacture, and distribution of medical devices.

The HSG Catheter will join the company’s expanding portfolio of women’s health products, with the goal of offering consistent, high-quality solutions to healthcare providers worldwide. With FDA clearance now in place, LI Medical Corporation is preparing for U.S. commercialization and distribution partnerships.