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Has the da Vinci Surgical System been cleared by the FDA?

The FDA cleared the da Vinci Surgical System to be used in both adult and pediatric robotic surgery for different types of surgical procedures such as urological surgeries, general laparoscopic surgeries, general non-cardiovascular thoracosopic surgeries, thoracoscopically assisted cardiotomy procedures.

The da Vinci Surgical System and FDA approval

  • In July 2000, the FDA cleared the da Vinci for general laparoscopic surgery as an endoscopic instrument control system for use in abdominal surgical procedures such as cholecystectomy (removal of the gallbladder) gastroesophageal reflux, and gynecologic surgery.

  • In March 2001, the FDA cleared the da Vinci for use in general non-cardiac thoracoscopic (inside the chest) surgical procedures, surgeries involving the lungs, esophagus, and the internal thoracic artery.
  • In June 2001, the FDA cleared the da Vinci for removal of the prostate (radical prostatectomy). The system is cleared by the FDA to manipulate tissue by grasping, cutting, dissecting, and suturing.
  • In November 2002, the FDA cleared the da Vinci for use in thoracoscopically assisted cardiotomy procedures and in mitral valve repair surgery.
  • In January 2003, the FDA cleared the da Vinci for use in totally endoscopic atrial septal defect (ASD).
  • In April 2005, the FDA cleared the da Vinci for use in gynecological procedures.
  • At the moment the da Vinci surgical system is the only robotic surgical system with FDA approval for intracardiac surgery.

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Source: https://www.cedars-sinai.edu/Education/Medical-Library/