CLEARSPEC SINGLE USE VAGINAL SPECULUM

CLEARSPEC SINGLE USE VAGINAL SPECULUM is an FDA 510(k)-cleared medical device (K130046) manufactured by Clearspec, 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 August 5, 2013. Regulation: 8.