Intuitive Announces Expanded FDA Clearance for da Vinci SP

Intuitive has announced that the U.S. Food and Drug Administration (FDA) has cleared the da Vinci Single Port (SP) surgical system for use in inguinal hernia repair, cholecystectomy, and appendectomy procedures.

These clearances expand da Vinci SP’s capabilities and build on its existing U.S. clearances in urology, colorectal, thoracic and transoral procedures.

“Da Vinci SP was designed to give surgeons advanced capability through a single port, offering the precision and control needed in narrow or deep anatomical spaces,” said Iman Jeddi, PhD, Senior Vice President and General Manager, da Vinci Platforms and Product Operations at Intuitive. “This clearance is one part of our innovation pathway for SP. We continue to evolve the platform with new tools and capabilities that help teams pursue less invasive approaches and expand what’s possible with da Vinci SP.”

The da Vinci SP system enables surgeons to perform procedures through a single incision or natural orifice, offering enhanced visualization and precision. Its design supports access to anatomy by allowing surgeons to control up to three multi-jointed instruments and an articulating 3DHD endoscope through one entry point.

“Advancing da Vinci SP is part of our long-term commitment to helping improve the future of patient care — supporting approaches that are less invasive, reduce recovery time, lower the total cost of care, and create a better experience for patients as they return to their lives,” said Myriam Curet, MD, Executive Vice President and Chief Medical Officer at Intuitive. “As we continue to innovate across our platforms, we remain focused on helping more patients access the benefits of minimally invasive care.”

A growing body of evidence, including more than 500 peer-reviewed publications, supports the safety, efficacy, and outcomes associated with the da Vinci SP system. SP is also approved for use in Europe, Japan, and Korea for a range of procedures spanning multiple surgical disciplines.

Source: Intuitive

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