510(k) K803214

ACMI BIPOLAR HEMOSTATIC ELECTRODE by American Cystocope Makers, Inc. — Product Code FEH

K803214 is an FDA 510(k) premarket notification submitted by American Cystocope Makers, Inc. for the device "ACMI BIPOLAR HEMOSTATIC ELECTRODE". The FDA issued a decision of Substantially Equivalent on January 15, 1981. The device falls under product code FEH (Electrode, Flexible Suction Coagulator), a Class II device regulated under 21 CFR 876.4300. American Cystocope Makers, Inc. has at least 8 other 510(k) clearances on record.