GYNECARE MORCELLEX TISSUE MORCELLATOR, MODELS MX0100 AND MX0100R

GYNECARE MORCELLEX TISSUE MORCELLATOR, MODELS MX0100 AND MX0100R is an FDA 510(k)-cleared medical device (K061050) manufactured by ETHICON, 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 July 13, 2006. Regulation: 8.