Medtronic Wins FDA Clearance for LigaSure RAS Maryland on Hugo Robot

Medtronic announced on September 16, 2026, that the U.S. Food and Drug Administration (FDA) has cleared the LigaSure RAS Maryland jaw device for use with the Hugo robotic-assisted surgery (RAS) system. The clearance expands the instrument lineup available on the Hugo system for U.S. robotic-assisted procedures.

The LigaSure RAS Maryland Instrument

According to Medtronic, the LigaSure RAS Maryland is built to work only with the Valleylab FT10 energy platform on the Hugo RAS system. The company said the instrument seals and cuts vessels, thick tissue, and lymphatics up to and including 7 mm in diameter, and that it seals vessels in approximately 2 seconds while limiting thermal spread to surrounding tissue.

Medtronic describes the LigaSure RAS Maryland as the first robotically driven LigaSure instrument, and said the vessel-sealing technology it incorporates has been used in more than 45 million procedures across more than 65 countries over the past two decades. The instrument was introduced on the Hugo RAS system in Europe in 2025 following CE Mark.

Medtronic’s product page for the device states that the jaw vessel sealer has reached the U.S. market, and describes it as pairing ValleyLab FT10 generator sealing with the versatility of the Hugo RAS system.

Hugo RAS Regulatory Path in the U.S.

The Hugo RAS system is cleared in the U.S. for urologic surgical procedures and, according to the company, is in commercial use at a growing number of health systems and hospitals across the country. Medtronic received FDA clearance for Hugo in urologic surgical procedures in December 2025.

In a June 3, 2026 announcement, Medtronic said it had submitted 510(k) filings to the FDA seeking clearance for Hugo system use in general surgery, including hernia repair, and in gynecologic surgery. That release also disclosed that a 510(k) filing for the LigaSure RAS Maryland instrument had been submitted and was pending. The clearance announced on September 16, 2026, covers that instrument.

The June announcement also disclosed FDA 510(k) clearance of ProGrip Advanced, a self-gripping polypropylene mesh cleared for use in robotic-assisted ventral hernia repair. Medtronic said ProGrip meshes have been used in more than 6 million procedures, and that nearly 470,000 ventral hernia repair procedures are performed in the U.S. each year.

Medtronic also reported in June that it had completed enrollment in the Embrace Gynecology Investigational Device Exemption (IDE) clinical study, a prospective multicenter study evaluating the safety and effectiveness of the Hugo RAS system in robotic-assisted gynecologic procedures. It enrolled 70 patients at 5 U.S. hospitals.

The company said general surgery and gynecologic surgery are specialties in which the Hugo system is already in clinical use in major markets outside the U.S., and that the filings are intended to broaden the platform’s clinical applicability in the U.S. In the June release, Medtronic described itself as the first and only company able to meet surgeons’ needs across all surgical modalities — open, laparoscopic, and robotic-assisted.

Surgeon Expectations and Global Use

Dr. Matthew Kroh, chief medical officer within Medtronic’s Surgical business and a practicing surgeon, said surgeons have trusted LigaSure vessel sealing across open and laparoscopic surgery for decades. “Bringing that same performance to the Hugo RAS system in the U.S. means surgeons carry the confidence and control they already rely on into their robotic-assisted cases,” Kroh said.

The company said that with robotic-assisted surgery adoption growing in the U.S., surgeons increasingly want the same energy instruments in a robotic workflow that they use in open and laparoscopic procedures.

Outside the U.S., Medtronic said the Hugo RAS system has been used with tens of thousands of patients in more than 35 countries, covering more than 50 different surgical procedures across urology, general, and gynecology indications. In June, the company said the system had nearly five years of commercial use across more than 35 countries on five continents, with hundreds of independently published scientific papers supporting its safety and effectiveness; that release put LigaSure technology use at more than 35 million procedures.

Matt Anderson, senior vice president and president of Medtronic’s Surgical business, said in June that the milestones would unlock the company’s ability to enhance the value of its partnership in general and gynecologic surgical procedures.

Medtronic said it continues to pursue plans to broaden Hugo’s U.S. indications to a wide range of soft-tissue procedures, including general and gynecologic surgery.