510(k) K152744

DIEGO ELITE DRILL by Gyrus Acmi, Inc. — Product Code ERL

K152744 is an FDA 510(k) premarket notification submitted by Gyrus Acmi, Inc. for the device "DIEGO ELITE DRILL". The FDA issued a decision of Substantially Equivalent on June 10, 2016. The device falls under product code ERL (Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece), a Class II device regulated under 21 CFR 874.4250. Gyrus Acmi, Inc. has at least 10 other 510(k) clearances on record.