Medtronic (NYSE: MDT) submitted 510(k) filings to the Food and Drug Administration seeking clearance to expand its Hugo robotic-assisted surgery system for use in general surgery and gynecologic procedures in the United States, according to a company statement.

The medical device company also announced it received FDA clearance for ProGrip Advanced self-gripping polypropylene mesh for robotic-assisted ventral hernia repair surgeries and submitted a 510(k) filing for its LigaSure RAS Maryland instrument on the Hugo system.

The Hugo system received FDA clearance for urologic surgical procedures in December 2025 and is currently in commercial use at U.S. medical centers. The system has been used commercially for nearly five years across more than 35 countries and has been utilized in tens of thousands of procedures.

Medtronic completed enrollment in its Embrace Gynecology Investigational Device Exemption clinical study for the Hugo system in the U.S. The prospective multicenter study evaluated the safety and effectiveness of the system for robotic-assisted gynecologic procedures and enrolled 70 patients across 5 U.S. hospitals.

The LigaSure RAS Maryland instrument is designed for use with the Valleylab FT10 energy platform on the Hugo system. LigaSure technology has been used in more than 35 million procedures across 65 countries, and the RAS version was introduced on the Hugo system in Europe in 2025.

ProGrip meshes have been used in more than 6 million procedures. Nearly 470,000 ventral hernia repair procedures are performed annually in the U.S., with an increasing number being performed with robotic assistance.