Medtronic’s Hugo robotic-assisted surgery system has cleared another FDA milestone. On September 16, 2026, the U.S. Food and Drug Administration cleared the LigaSure RAS Maryland jaw device for use with the Hugo RAS system.
The clearance brings a vessel-sealing and tissue-cutting instrument to the U.S. version of the robotic platform, building on technology used in more than 45 million procedures across more than 65 countries over the past two decades. What does the device add? A tool designed to seal and cut vessels, thick tissue, and lymphatics up to and including 7 mm in diameter.
A New Instrument for the Hugo Surgical Platform
The LigaSure RAS Maryland is built to work only with the Valleylab FT10 energy platform on the Hugo RAS system. That pairing connects the robotic instrument with the energy platform required for its vessel-sealing function.
The device seals vessels in approximately 2 seconds while limiting thermal spread to surrounding tissue. It also cuts vessels, thick tissue, and lymphatics up to and including 7 mm in diameter, giving the instrument a defined range for the procedures covered by its design.
The LigaSure RAS Maryland already reached the Hugo RAS system in Europe in 2025 following CE Mark. The September 16, 2026, FDA clearance covers the LigaSure RAS Maryland instrument in the United States.
That timing follows a clear regulatory path. Medtronic received FDA clearance for the Hugo RAS system in urologic surgical procedures in December 2025, and the system is cleared in the U.S. for those procedures.
More FDA Filings Point Toward Surgical Expansion
Medtronic has also submitted 510(k) filings to the FDA seeking clearance for Hugo system use in general surgery, including hernia repair, and in gynecologic surgery. The LigaSure RAS Maryland instrument had its own 510(k) filing submitted and pending as of June 3, 2026.
That pending filing now has an outcome: the FDA clearance announced on September 16, 2026, covers the LigaSure RAS Maryland instrument. The clearance adds a specific instrument to the Hugo system as Medtronic pursues regulatory progress across more surgical areas.
Gynecology remains part of that broader effort. In June, Medtronic reported that it had completed enrollment in the Embrace Gynecology Investigational Device Exemption clinical study, enrolling 70 patients at 5 U.S. hospitals.
The company’s filings and clinical work place the Hugo RAS system within a wider set of surgical applications, but the FDA clearance described here covers the LigaSure RAS Maryland instrument. The system’s U.S. clearance for urologic surgical procedures dates to December 2025, while the general surgery and gynecologic surgery filings seek additional clearance.
Why Vessel Sealing Matters for the Platform
Vessel sealing sits at the center of the instrument’s purpose. The LigaSure RAS Maryland can seal vessels in approximately 2 seconds and cut vessels, thick tissue, and lymphatics up to and including 7 mm in diameter, while its design limits thermal spread to surrounding tissue.
The underlying vessel-sealing technology brings a long procedural record. It has been used in more than 45 million procedures across more than 65 countries over the past two decades, giving the technology a substantial history behind its use with the robotic instrument.
Medtronic is also connecting its surgical portfolio to the U.S. hernia market. The company said ProGrip meshes have been used in more than 6 million procedures, while nearly 470,000 ventral hernia repair procedures are performed in the U.S. each year.
Those figures explain why general surgery and hernia repair appear in Medtronic’s 510(k) filings for Hugo. The filings seek clearance for use of the Hugo system in general surgery, including hernia repair, but the facts available here do not state that those clearances have been granted.
The next phase for Hugo will depend on those regulatory filings, the gynecologic surgery effort, and the instruments cleared for the system. For now, the FDA clearance dated September 16, 2026, gives Medtronic’s robotic platform a LigaSure RAS Maryland device designed for vessel sealing and cutting, tied to the Valleylab FT10 energy platform and backed by technology used across millions of procedures.
