TRUCLEAR MORCELLATION SYSTEM AND TRUCLEAR MORCELLATORS

TRUCLEAR MORCELLATION SYSTEM AND TRUCLEAR MORCELLATORS is an FDA 510(k)-cleared medical device (K132015) manufactured by Smith & Nephew, Inc.. This device is classified under the Obstetrics/Gynecology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 12, 2013. Regulation: 8.