FDA Clears Intuitive’s First Single-Port Robotic Surgery Stapler for Broader Use

On April 10, 2025, Intuitive Surgical received FDA clearance for its SP SureForm 45 stapler, the first stapler designed specifically for single-port robotic surgery. The stapler, compatible with the da Vinci SP surgical system, is now approved for thoracic, colorectal, and urologic procedures in the U.S.

The SP SureForm 45 features SmartFire technology, which optimizes staple formation by adjusting to tissue thickness in real time, aiming to improve surgical precision and safety. It gives surgeons full control from the console without needing an assistant to operate the stapler, potentially saving time during operations.

This clearance expands the capabilities of Intuitive’s da Vinci SP system, already used internationally for a range of procedures. The stapler is not approved for transoral otolaryngology in the U.S. Intuitive emphasized its commitment to developing less invasive surgical technologies that enhance outcomes and recovery for patients.