
United States Surgical, A Division of Tyco Healthc
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THE AUTO SUTURE* MIBB** SYSTEM is an FDA 510(k)-cleared medical device (K973496) manufactured by United States Surgical, A Division of Tyco Healthc. 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 November 30, 1997. Regulation: 8.