510(k) K231554

UniPearls® Embolic Microspheres by Suzhou Haowei Medical Technology Co., Ltd. — Product Code KRD

K231554 is an FDA 510(k) premarket notification submitted by Suzhou Haowei Medical Technology Co., Ltd. for the device "UniPearls® Embolic Microspheres". The FDA issued a decision of Substantially Equivalent on November 14, 2023. The device falls under product code KRD (Device, Vascular, For Promoting Embolization), a Class II device regulated under 21 CFR 870.3300.