Intuitive Gets FDA’s 510(k) Clearance for Its Surgical Stapler
Sunnyvale, Calif.-based Intuitive has received the FDA’s 510(k) marketing clearance for its SureForm 30 surgical stapler.
The device, which features an 8-mm diameter instrument shaft and a curved tip, is designed for use in general, thoracic, gynecologic, urologic and pediatric surgery. The stapler fits through Intuitive’s 8-mm da Vinci surgical instrument cannula, enabling surgeons to approach the patient’s anatomy from different angles.
The company, which specializes in minimally invasive care and robotic-assisted surgery, says it will start marketing the SureForm 30 stapler in the U.S. in the new year.