Intuitive wins FDA clearance for single-port robotic surgery stapler

A gloved hand holds a syringe filled with yellow liquid, injecting it into a red apple alongside two other syringes containing different substances, symbolizing food safety and regulatory practices.

Intuitive Surgical announced that the FDA had cleared its SP Sureform 45 stapler with its da Vinci SP (single-port) robotic surgery system, marking the first stapler designed specifically for single-port robotic procedures. This clearance is significant for Intuitive’s commercial strategy, as the stapler is essential for the adequate performance of thoracic and colorectal surgeries—two key indications the FDA recently approved for the single-port system. CFO Jamie Samath previously emphasized the stapler's role in scaling adoption, noting that its availability would trigger "broad commercial efforts" to support these applications.

The da Vinci SP system, introduced in 2018, allows surgeons to operate through a single incision, offering improved access in narrow anatomical areas compared to multi-port systems. The newly cleared stapler incorporates Smartfire technology, which monitors tissue compression to reduce damage and enhance staple line integrity. While the SP system complements Intuitive’s well-established multi-port robots, questions remain about how it will compete in a market with high penetration and emerging rivals like Vicarious Surgical. Nonetheless, the stapler’s approval positions Intuitive to strengthen its footprint in robotic-assisted surgery, particularly in procedures where single-port access provides distinct clinical advantages.