510(k) K161176

ARTOURA Breast Tissue Expanders with Smooth Surface by Mentor Worldwide, LLC — Product Code LCJ

K161176 is an FDA 510(k) premarket notification submitted by Mentor Worldwide, LLC for the device "ARTOURA Breast Tissue Expanders with Smooth Surface". The FDA issued a decision of Substantially Equivalent on May 23, 2016. The device falls under product code LCJ (Tissue Expander And Accessories), a Class U device. Mentor Worldwide, LLC has at least 10 other 510(k) clearances on record.