510(k) K183163

Intraoperative, Single-Use, Sterile, Silicone Breast Sizer Motiva Implant Matrix by Motiva USA, LLC — Product Code MRD

K183163 is an FDA 510(k) premarket notification submitted by Motiva USA, LLC for the device "Intraoperative, Single-Use, Sterile, Silicone Breast Sizer Motiva Implant Matrix". The FDA issued a decision of Substantially Equivalent on February 5, 2019. The device falls under product code MRD (Mammary Sizer), a Class U device. Motiva USA, LLC has at least 1 other 510(k) clearance on record.