Integrated Surgical Systems
This article was originally published in The Gray Sheet
Executive Summary
Robotic surgery products maker announces Sept. 22 that FDA may reclassify its Robodoc surgical assistant system from Class III to Class II. Reclassification would allow the product to be cleared to market through the 510(k) process. Data generated from the DigiMatch Robodoc system multicenter clinical trial will be used to support the reclassification submission, ISS says. In May, agency officials notified competitor Intuitive Surgical that it could submit a 510(k) for cardiovascular use of the da Vinci tele-robotic endoscopic surgical system, rather than proceeding through the premarket approval application process (1"The Gray Sheet" July 17, 2000, p. 12)