Regulator
The FDA cleared da Vinci 5 through the 510(k) route.
A regulator's decision · Sets da Vinci 5's stage
What the source says
“has secured FDA 510(k) clearance for its next-generation da Vinci 5 multiport surgical robotics system.”
What it means
da Vinci 5, from Intuitive, is at stage 5 of 5 on our ladder: regulator-cleared or mass market. This event is one of the milestones that placed it there.
Human help: A surgeon in the operating room controls it; it doesn't operate on its own.
More on da Vinci 5
- Intuitive said it placed 315 da Vinci 5 systems in the third quarter of 2026, up from 240 a year earlier.
- Intuitive placed 246 da Vinci 5 systems with hospitals in the second quarter of 2026, up from 180 a year earlier.
- The FDA cleared da Vinci 5 for certain heart operations, such as mitral valve repair, done through small cuts between the ribs.
- Intuitive started a Class 2 recall covering da Vinci X, Xi and da Vinci 5. A software error let instrument arms that failed a safety self-test stay in use.
- da Vinci 5 received the CE mark, which allows it to be sold in Europe, for adults and children.
- Intuitive began its full commercial rollout of da Vinci 5 in the US in 2025.