FDA Grants Expanded Approval for Intuitive Surgical’s Robot-Assisted Surgery Device

Intuitive Surgical received 510(k) clearance for a new indication for its da Vinci SP robot-assisted surgery device.

The new indication is for urologic surgical procedures that require very narrow access from a small incision appropriate for a single port approach. The company plans to pursue additional clearances for other applications.

The system includes three multi-jointed wristed instruments and a fully wristed 3D HD camera. The system allows for flexible port placement and 360 degrees of anatomical access.