Medtronic has filed for 510(k) clearance with the FDA to expand the use of its Hugo robotic-assisted surgery (RAS) system into general and gynecologic surgeries in the United States.
The Hugo RAS system, which received FDA clearance for urologic surgical procedures in December 2025, is already being used at leading US medical centers. According to the company, the Hugo RAS system has been used in tens of thousands of procedures, with its safety and effectiveness is supported by hundreds of independently published scientific papers.
Medtronic said the latest 510(k) filings cover general surgical procedures, including hernia repair, as well as gynecological surgeries.
“These milestones and innovative technologies will unlock our ability to enhance the value of our partnership in general and gynecologic surgical procedures,” said Matt Anderson, senior vice president and president of the Surgical business at Medtronic.
“This isn’t just a portfolio expansion, it’s part of our ongoing commitment to unite instruments, intelligence, and human hands into one unique surgical ecosystem. One that enables every patient, everywhere, access to the best possible surgery,” he added.
The company has also submitted a separate 510(k) filing for the LigaSure RAS Maryland instrument, designed exclusively for use with the Valleylab FT10 Energy Platform on the Hugo RAS system. LigaSure technology, which has been used in more than 35 million procedures across over 65 countries, was introduced on the Hugo RAS system in Europe in 2025.
Dr. Matthew Kroh, chief medical officer within the Surgical business at Medtronic and a practicing general surgeon, said, “LigaSure technology has been transformative for surgery and integrating it onto the Hugo RAS system gives surgeons greater confidence and control during critical moments in complex procedures.”
“As more and more surgeons and patients demand robotic-assisted surgery, we need more access to technology and training, and Medtronic brings that choice in a very powerful way,” he noted.
In addition, Medtronic announced it has received FDA clearance for ProGrip Advanced, a next-generation mesh designed for robotic-assisted ventral hernia repair.
According to the company, ProGrip meshes have been used in more than 6 million procedures worldwide. The new ProGrip Advanced mesh is designed to improve surgical efficiency by making it easier to introduce through trocars, handle, deploy, and unfold during robotic procedures. It is available in multiple sizes to suit different patient needs.
Medtronic also confirmed completion of enrollment in the Embrace Gynecology Investigational Device Exemption (IDE) clinical study for the Hugo RAS system in the US. The prospective multicenter study is evaluating the safety and effectiveness of the Hugo RAS system in robotic-assisted gynecologic procedures and enrolled 70 patients across five US hospitals.
Hugo RAS System – Photo: Medtronic
