Intuitive Surgical, Inc. - FDA 510(k) Cleared Devices
Intuitive Surgical, Inc. is an American biotechnology company headquartered in Sunnyvale that develops and manufactures robotic surgical systems. The company specializes in minimally invasive surgery technologies, most notably the da Vinci Surgical System.
Intuitive Surgical has received 156 FDA 510(k) clearances from 176 total submissions since its first clearance in 1997. The company's dominant focus is General & Plastic Surgery devices, which represent 87% of its regulatory submissions. The latest FDA 510(k) clearance was granted in 2026, reflecting continued innovation and active market presence.
Recent cleared devices include advanced surgical instruments, generator systems, and specialized endoluminal platforms across multiple surgical specialties. The company maintains a significant global installed base of robotic surgical systems across the United States, Europe, Asia, and other regions.
Explore the complete regulatory record by reviewing individual device names, product codes, and clearance dates in the database.
FDA 510(k) cleared devices by Intuitive Surgical, Inc.
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