
Covidien, Formerly US Surgical A Divison of Tyco H
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IDRIVE ULTRA POWERED HANDLE AND ENDO GIA ADAPTER is an FDA 510(k)-cleared medical device (K123318) manufactured by Covidien, Formerly US Surgical A Divison of Tyco H. 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 December 17, 2012. Regulation: 8.