G-SPEC ARTICULATED WEIGHTED VAGINAL SPECULUM

G-SPEC ARTICULATED WEIGHTED VAGINAL SPECULUM is an FDA 510(k)-cleared medical device (K052420) manufactured by Gynova, LLC. 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 5, 2006. Regulation: 8.