FDA Clearance
The U.S. Food and Drug Administration (FDA) has cleared the da Vinci® Surgical System for adult and pediatric use in urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, general non-cardiovascular thoracoscopic surgical procedures and thoracoscopically assisted cardiotomy procedures. The da Vinci System may also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization.
Representative Uses: The da Vinci System has been successfully used in the following procedures, among others:
- Radical prostatectomy, pyeloplasty, cystectomy, nephrectomy, ureteral reimplantation
- Hysterectomy, myomectomy and sacrocolpopexy
- Cholecystectomy, Nissen fundoplication, Heller myotomy, gastric bypass, donor nephrectomy, adrenalectomy, splenectomy and bowel resection
- Internal mammary artery mobilization and cardiac tissue ablation
- Mitral valve repair, endoscopic atrial septal defect closure
- Mammary to left anterior descending coronary artery anastomosis for cardiac revascularization with adjunctive mediastinotomy