510(k) K222001

Irreversible Electroporation Ablation Generator, Irreversible Electroporation Probe by Zhejiang Curaway Medical Technology Co., Ltd. — Product Code OAB

K222001 is an FDA 510(k) premarket notification submitted by Zhejiang Curaway Medical Technology Co., Ltd. for the device "Irreversible Electroporation Ablation Generator, Irreversible Electroporation Probe". The FDA issued a decision of Substantially Equivalent on June 8, 2023. The device falls under product code OAB (Low Energy Direct Current Thermal Ablation System), a Class II device regulated under 21 CFR 878.4400. Zhejiang Curaway Medical Technology Co., Ltd. has at least 5 other 510(k) clearances on record.