Robotic Single-Port System Gains CE Mark for Transvaginal Gynecologic Procedures

Intuitive (Sunnyvale, CA, USA) announced that it has received CE mark approval for use of the da Vinci SP Single Port surgical system in transvaginal gynecologic procedures, marking the first such indication for the SP platform worldwide. The system is part of Intuitive’s family of robotic-assisted platforms designed to support minimally invasive surgery with high-definition 3D vision, magnified views, and computer-assisted instrumentation across multiple surgical disciplines.

The da Vinci SP system enables procedures through a single incision or natural orifice and is designed to enhance visualization and precision in narrow or deep anatomical spaces. From one entry point, surgeons can control up to three multi-jointed instruments and a fully articulating 3DHD endoscope, providing access to complex anatomy while minimizing disruption to surrounding tissue.

The CE mark approval, granted September 14, 2026, expands the system’s CE-marked applications in Europe, which already include endoscopic abdominopelvic, thoracoscopic, transoral otolaryngology, transanal colorectal, and breast surgical procedures. The system is also approved for use in the United States, Japan, and Korea for a range of procedures.

A growing body of evidence, including more than 1,000 peer-reviewed publications, supports the safety, efficacy, and patient outcomes associated with the platform. Across da Vinci surgical systems, surgeons use specialized instrumentation designed to support precise dissection and reconstruction deep inside the body.

“Building on the strong adoption of da Vinci SP in women's health, this approval is a meaningful step forward, not just as a regulatory milestone, but because it expands access to less invasive options for women across Europe and opens the door to potentially better recovery experiences and outcomes,” said Dirk Barten, Intuitive commercial president for Europe.

“Transvaginal procedures expand the natural orifice surgery portfolio of the da Vinci SP System, which to this day includes successful transoral and transanal procedures. These less invasive, scarless surgery approaches have the potential to shorten recovery times and enhance patients' experience as they return to their daily lives. As we continue to innovate across our platforms, we remain focused on helping more patients access the benefits of minimally invasive care,” said Tilman Schlick, vice president, medical affairs & medical officer at Intuitive in Europe.