510(k) K163050

Advance Medical Designs, Inc. Sterile Ultrasound Gel by Advance Medical Designs, Inc. — Product Code MUI

K163050 is an FDA 510(k) premarket notification submitted by Advance Medical Designs, Inc. for the device "Advance Medical Designs, Inc. Sterile Ultrasound Gel". The FDA issued a decision of Substantially Equivalent on October 25, 2017. The device falls under product code MUI (Media, Coupling, Ultrasound), a Class II device regulated under 21 CFR 892.1570. Advance Medical Designs, Inc. has at least 10 other 510(k) clearances on record.