Intuitive Surgical Releases Status Update on Stapler Clearances

Intuitive Surgical released a status update Tuesday of clearances in Europe, South Korea and the U.S. for its robotically assisted da Vinci surgical systems.

The EndoWrist stapler for the da Vinci Si and Xi systems won CE Mark certification in April; the EndoWrist stapler for the da Vinci Si system gained approval in South Korea the first quarter of this year; and the EndoWrist stapler for the da Vinci Si and Xi systems received FDA 510(k) clearance in 2012 and 2014, respectively.

The staplers are meant for use in resection, transection and/or creation of surgical connections between vessels in general, gynecologic and urologic surgery, the Sunnyvale, Calif., devicemaker says. Additionally, the da Vinci Xi EndoWrist stapler can be used for thoracic surgery.

The company expects approvals in South Korea and Japan later this year. — Jason Scott