510(k) K203739

ELAN 4 Electro Motor System by Aesculap, Inc. — Product Code HBE

K203739 is an FDA 510(k) premarket notification submitted by Aesculap, Inc. for the device "ELAN 4 Electro Motor System". The FDA issued a decision of Substantially Equivalent on August 24, 2021. The device falls under product code HBE (Drills, Burrs, Trephines & Accessories (Simple, Powered)), a Class II device regulated under 21 CFR 882.4310. Aesculap, Inc. has at least 10 other 510(k) clearances on record.