
Intuitive Surgical, Inc.
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da Vinci S/Si EndoWrist Instruments and Accessories, Harmonic ACE Curved Shears (5mm & 8mm) is an FDA 510(k)-cleared medical device (K170644) manufactured by Intuitive Surgical, Inc.. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 10, 2017. Regulation: 8.