HEM-AVERT PERIANAL STABILIZER

HEM-AVERT PERIANAL STABILIZER is an FDA 510(k)-cleared medical device (DEN090011) manufactured by Plexus Biomedical, 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 January 12, 2011. Regulation: 8.