G-SPERM, MODEL 10032

G-SPERM, MODEL 10032 is an FDA 510(k)-cleared medical device (K022247) manufactured by Vitrolife Sweden AB. 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 September 5, 2002. Regulation: 8.