510(k) K122605

PKS BILL by Gyrus Acmi, Inc. — Product Code HIN

K122605 is an FDA 510(k) premarket notification submitted by Gyrus Acmi, Inc. for the device "PKS BILL". The FDA issued a decision of Substantially Equivalent on December 5, 2012. The device falls under product code HIN (Coagulator-Cutter, Endoscopic, Bipolar (And Accessories)), a Class II device regulated under 21 CFR 884.4150. Gyrus Acmi, Inc. has at least 10 other 510(k) clearances on record.