FDA Clears Medtronic's LigaSure Vessel Sealer for Use With the Hugo Surgical Robot

The FDA has cleared Medtronic's LigaSure RAS Maryland jaw device for use with the company's Hugo robotic-assisted surgery system, bringing its vessel-sealing instrument to US robotic procedures for the first time, Medtronic announced on September 16.

The FDA's 510(k) database lists submission K261070, the "LigaSure™ RAS Maryland Jaw Vessel Sealer/Divider, Nano-coated," from Covidien, LLC, the Medtronic unit in Lafayette, Colorado. The submission was received on April 1, 2026 and found substantially equivalent on September 15. It is classified under regulation 878.4400 as an electrosurgical cutting and coagulation device, product code GEI, and was reviewed as a traditional 510(k) by the general and plastic surgery panel.

What the instrument does

According to Medtronic, the instrument is designed exclusively for use with the Valleylab FT10 energy platform on the Hugo system. It "seals and cuts vessels, thick tissue, and lymphatics up to and including 7 mm in diameter, sealing vessels in approximately 2 seconds while minimizing thermal spread to surrounding tissue," the company said.

Medtronic described it as the first robotic-driven LigaSure instrument and said LigaSure technology has been used in more than 45 million procedures in more than 65 countries over the past two decades. The instrument was introduced on Hugo in Europe in 2025 after receiving a CE mark. MedTech Dive reported that the CE mark came in July 2025.

"Vessel sealing sits at the center of how surgeons work through the most demanding moments of a procedure, and surgeons have trusted LigaSure to do it across open and laparoscopic surgery for decades," said Matthew Kroh, chief medical officer in Medtronic's surgical business. "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."

Hugo's US indications

In the US, Hugo is cleared for urologic procedures, Medtronic said. The company said it is "continuing to progress its plans" to expand Hugo's US indications to other soft-tissue procedures, including general and gynecologic surgery. MedTech Dive reported that Medtronic disclosed in June that it had filed for 510(k) clearance of the LigaSure instrument on Hugo, as part of a set of submissions meant to widen the instruments and indications cleared for the platform.

Outside the US, Medtronic said, Hugo is used in more than 35 countries across more than 50 procedure types in urology, general surgery and gynecology.

MedTech Dive described the clearance as part of Medtronic's effort to compete with Intuitive in robotic surgery by pairing its platform with energy instruments surgeons already use in open and laparoscopic operations. The outlet reported that chief executive Geoff Martha said on the company's first-quarter earnings call this month that Medtronic expects Hugo to pass 50,000 completed procedures in its financial year, which ends in late April.

Medtronic did not give pricing or a date for US availability of the instrument in its announcement.