GEL-SPONGE ENT, ABSORBABLE GELATIN SPONGE, USP

GEL-SPONGE ENT, ABSORBABLE GELATIN SPONGE, USP is an FDA 510(k)-cleared medical device (K080022) manufactured by Vascular Solutions, Inc.. This device is classified under the Ear, Nose, Throat specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 8, 2008. Regulation: 8.