510(k) K091139

CONMED AER DEFENSE SMOKE EVACUATOR by Conmed Corporation — Product Code FYD

K091139 is an FDA 510(k) premarket notification submitted by Conmed Corporation for the device "CONMED AER DEFENSE SMOKE EVACUATOR". The FDA issued a decision of Substantially Equivalent on May 5, 2009. The device falls under product code FYD (Apparatus, Exhaust, Surgical), a Class II device regulated under 21 CFR 878.5070. Conmed Corporation has at least 10 other 510(k) clearances on record.