Intuitive Surgical Gets FDA Clearance For Da Vinci Sp Surgical System

(RTTNews) - Sunnyvale, California-based Intuitive Surgical Inc (ISRG) said it obtained FDA 510(k) clearance for the da Vinci Sp Surgical System, designed to expand its single-incision product offering. The company further said this initial clearance is specific to urologic surgical procedures that are appropriate for a single port approach.

Intuitive Surgical noted that it 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.

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 25 mm cannula. The surgeon controls the instruments and endoscope while seated at the da Vinci Surgical System console.