Medtronic files 510(k)s to expand Hugo into general surgery and gynecology

On June 3, 2026 Medtronic said it had submitted 510(k) filings with the FDA to expand its Hugo robotic-assisted surgery system into general and gynecologic specialties in the U.S. Hugo's only current U.S. indication is urology, cleared in December 2025. Intuitive's da Vinci is the established system in these specialties, so new clearances would bring a direct rival into them.

• 510(k) submissions announced June 3, 2026
• Filings cover general surgery and gynecologic specialties
• Hugo's only current U.S. indication is urology, cleared in December 2025