We are pleased to announce that LI Medical Corporation has received U.S. FDA 510(k) clearance (K240364) for our Uterine Manipulator Injector, a key advancement in our expanding portfolio of OB/GYN surgical solutions.

This newly cleared device is designed to assist gynecologic surgeons with optimal uterine positioning, manipulation, and injection during laparoscopic and hysteroscopic procedures. Engineered for safety, precision, and ease of use, the Uterine Manipulator Injector offers enhanced control and visibility, supporting improved outcomes in minimally invasive gynecologic surgeries.

The FDA clearance further validates LI Medical’s commitment to developing high-quality, clinician-focused devices that meet stringent U.S. regulatory standards. Manufactured in our ISO 13485 certified facility, the device is backed by years of contract manufacturing experience for major U.S. OB/GYN brands — now available under our own name.

This milestone marks another step forward in our mission to deliver reliable and innovative women’s health products to healthcare providers and patients worldwide.