IS4000 Stapler 30 Instrument and Stapler 30 Reloads

IS4000 Stapler 30 Instrument and Stapler 30 Reloads is an FDA 510(k)-cleared medical device (K152421) 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 March 3, 2016. Regulation: 8.