510(k) K161744

Symmetry Sharp Kerrison Rongeur by Symmetry Surgical, Inc. — Product Code HAE

K161744 is an FDA 510(k) premarket notification submitted by Symmetry Surgical, Inc. for the device "Symmetry Sharp Kerrison Rongeur". The FDA issued a decision of Substantially Equivalent on September 7, 2016. The device falls under product code HAE (Rongeur, Manual), a Class II device regulated under 21 CFR 882.4840. Symmetry Surgical, Inc. has at least 4 other 510(k) clearances on record.