510(k) K243042

Co-Ablation System with Sterile Co-Ablation Probe by Hygea Medical Technology Co., Ltd. — Product Code GEH

K243042 is an FDA 510(k) premarket notification submitted by Hygea Medical Technology Co., Ltd. for the device "Co-Ablation System with Sterile Co-Ablation Probe". The FDA issued a decision of Substantially Equivalent on January 29, 2025. The device falls under product code GEH (Unit, Cryosurgical, Accessories), a Class II device regulated under 21 CFR 878.4350. Hygea Medical Technology Co., Ltd. has at least 1 other 510(k) clearance on record.