510(k) K243032

EHL Probe (SCDG-AS); EHL Probe (SCDG-BS); EHL Probe (SCDG-CS) by Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. — Product Code FFK

K243032 is an FDA 510(k) premarket notification submitted by Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. for the device "EHL Probe (SCDG-AS); EHL Probe (SCDG-BS); EHL Probe (SCDG-CS)". The FDA issued a decision of Substantially Equivalent on March 21, 2025. The device falls under product code FFK (Lithotriptor, Electro-Hydraulic), a Class II device regulated under 21 CFR 876.4480. Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. has at least 6 other 510(k) clearances on record.