Intuitive Surgical’s da Vinci SP Gains FDA Clearance for Hernia, Gallbladder, and Appendectomy Procedures

Intuitive Surgical announced that its da Vinci SP single-port surgical robot has received FDA clearance for inguinal hernia repair, gallbladder removal, and appendectomy procedures. These new indications expand the platform’s use beyond urology, colorectal, thoracic, and transoral surgeries.

The SP system, designed for surgery through a single incision or natural orifice, allows surgeons to manipulate up to three multi-jointed instruments and a 3D-HD endoscope, enabling access to narrow or deep anatomical spaces for complex procedures. Compared with Intuitive’s multiport robots, the SP system represents a smaller portion of its installed base, with over 290 SP units globally versus nearly 9,900 multiport systems.

Procedures using the SP robot increased 91% in Q3 2025, and the company expects adoption to grow with the new clearances. Intuitive has also submitted regulatory applications for nipple-sparing mastectomy and other general surgeries. Competitors in the single-port space include Virtual Incision and Vicarious Surgical.

19-12-2025