
Covidien, LLC, Formerly Registered AS Tyco Healthca
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IDRIVE SYSTEM (I DRIVE POWER HANDLE, IDRIVE (RALC) SINGLE USE RELOAD) is an FDA 510(k)-cleared medical device (K102325) manufactured by Covidien, LLC, Formerly Registered AS Tyco Healthca. 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 October 12, 2010. Regulation: 8.