Intuitive Surgical Planning July 510(k) For da Vinci Cardiovascular Use
This article was originally published in The Gray Sheet
Executive Summary
Intuitive Surgical is planning to submit a 510(k) for cardiovascular use of the firm's da Vinci tele-robotic endoscopic surgical system rather than proceeding through the premarket approval process.
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Intuitive Surgical da Vinci
Surgical robotic system gains FDA market go-ahead for use in thoracoscopic surgical procedures. The device was cleared for general laparoscopic surgery in July (1"The Gray Sheet" July 17, 2000, p. 12)