
Surgical Devices, A Divsion of Tyco Healthcare
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AUTOSUTURE ENDO GIA SINGLE USE BLACK RELOAD WITH TRI-STAPLE TECHNOLOGY is an FDA 510(k)-cleared medical device (K093410) manufactured by Surgical Devices, A Divsion of Tyco Healthcare. This device is classified under the General, Plastic Surgery specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 11, 2009. Regulation: 8.