510(k) K250141

Synthecure Synthetic Calcium Sulfate by Austin Medical Ventures, Inc. — Product Code MQV

K250141 is an FDA 510(k) premarket notification submitted by Austin Medical Ventures, Inc. for the device "Synthecure Synthetic Calcium Sulfate". The FDA issued a decision of Substantially Equivalent on May 16, 2025. The device falls under product code MQV (Filler, Bone Void, Calcium Compound), a Class II device regulated under 21 CFR 888.3045.