510(k) K143078

Bookwalter Gordon Adjustable Compression Element by Symmetry Surgical — Product Code DXC

K143078 is an FDA 510(k) premarket notification submitted by Symmetry Surgical for the device "Bookwalter Gordon Adjustable Compression Element". The FDA issued a decision of Substantially Equivalent on May 14, 2015. The device falls under product code DXC (Clamp, Vascular), a Class II device regulated under 21 CFR 870.4450. Symmetry Surgical has at least 4 other 510(k) clearances on record.