510(k) K183545

Anspach Helix Dissection Tools by The Anspach Effort, Inc. — Product Code HBE

K183545 is an FDA 510(k) premarket notification submitted by The Anspach Effort, Inc. for the device "Anspach Helix Dissection Tools". The FDA issued a decision of Substantially Equivalent on July 19, 2019. The device falls under product code HBE (Drills, Burrs, Trephines & Accessories (Simple, Powered)), a Class II device regulated under 21 CFR 882.4310. The Anspach Effort, Inc. has at least 10 other 510(k) clearances on record.