PICSI SPERM SELECTION DEVICE

PICSI SPERM SELECTION DEVICE is an FDA 510(k)-cleared medical device (K052457) manufactured by Biocoat, 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 April 12, 2006. Regulation: 8.