Dextera Surgical Wins Expanded FDA Clearance for MicroCutter 5/80 Stapler
Dextera Surgical won expanded FDA 510(k) clearance for its MicroCutter 5/80 stapler and associated reloads, now cleared for open solid organ dissection techniques. The new clearance covers use on organs including the liver, kidney, pancreas and spleen.
The device is designed for transection and resection procedures in multiple open or minimally invasive urologic, thoracic and pediatric surgical procedures or creation of anastomoses in the small and large intestine and the transection of the appendix.
The expanded indication represents an additional 44,000 procedures in the United States annually.