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FDA 510(k) for da Vinci Sp Surgical System

Manufacturing Group | April 28, 2014

Initial clearance is specific to urologic surgical procedures that are appropriate for a single port approach.

FDA 510(k) for da Vinci Sp Surgical System

Sunnyvale, California – Intuitive Surgical Inc., the global leader in robotic-assisted minimally invasive surgery, has received FDA 510(k) clearance for the da Vinci Sp Surgical System, which is designed to expand the company's single-incision product offering. This initial clearance is specific to urologic surgical procedures that are appropriate for a single port approach.

"Our development of this single-port technology represents our foundational commitment to advancing tools for minimally invasive surgery," said Gary Guthart, Intuitive Surgical's president and CEO.

da VinciSp technology is a dedicated single-port innovation designed to deliver an articulating 3D HD camera and three fully articulating instruments through a single 25mm cannula. The fully wristed EndoWrist Sp Instruments have two more degrees of freedom than the da VinciSingle-Site Instruments, which are not wristed and are used in single port surgeries. The surgeon controls the instruments and endoscope while seated at the da Vinci Surgical System console.

The Company does not intend to commercialize the da Vinci Sp technology until the current technology is engineered to be fully compatible with the newly released da Vinci Xi Surgical System, currently projected for the second half of 2015. This will require product refinements, supply chain optimization and additional regulatory clearances.

Source: Intuitive Surgical

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