Intuitive Surgical (NSDQ:ISRG) shares opened up 11% this morning, after the medical device company said the FDA cleared the latest version of its da Vinci surgical robot, and quickly surged past the $500 mark..

Intuitive said it plans to have its da Vinci Xi device immediately on the U.S. market now that it’s got 510(k) clearance from the FDA, and "will be seeking regulatory clearances to market the da Vinci Xi System around the world."

"Our goal is to develop technology that enhances surgical performance," president & CEO Gary Guthart said in prepared remarks. "The da Vinci Xi System’s new overhead architecture means that multi-quadrant surgery can be performed without repositioning the system, an innovation long sought by surgeons who perform complex procedures. We strive to provide the most advanced, least invasive option for surgery, and we are working hard to make minimally invasive surgery the standard of care."

Intuitive said the Xi system "can be used across a wide spectrum of minimally invasive surgical procedures and has been optimized for complex, multi-quadrant surgeries." Other enhancements include improved overhead architecture of the devices 5 arms "to facilitate anatomical access from virtually any position" and new joints for greater range of motion, according to a press release. Intuitive said it also improved the endoscope on the da Vinci Xi for "a simpler, more compact design with improved visual definition and clarity" and to enable it to be attached to any of the device’s arms. The new da Vinci also has longer instrument shafts "to give surgeons greater operative reach," the company said.

The da Vinci Xi is designed to accommodate Intuitive’s Firefly fluorescent imaging system, although the FDA hasn’t cleared Firefly for use with the Xi yet, according to the release. Intuitive said it plans to seek clearance for use of the Firefly with the da Vinci Xi and will continue to offer its older da Vinci Si and Si-e systems.

ISRG shares gained 9.8% in pre-market trading, to $481 apiece as of about 9:20 this morning, before opening at $486.05, up 11.0%. Shares were trading at $501.77 each by about 10 a.m., up 14.6%.

Last week Intuitive recalled cannulae used during procedures with da Vinci procedures, saying they can become damaged if not installed properly.