About This 510(k) Submission
K243032 is an FDA 510(k) clearance for the EHL Probe (SCDG-AS); EHL Probe (SCDG-BS); EHL Probe (SCDG-CS), a Lithotriptor, Electro-hydraulic (Class II — Special Controls, product code FFK), submitted by Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. (Guangzhou, CN). The FDA issued a Cleared decision on March 21, 2025, 175 days after receiving the submission on September 27, 2024. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.4480.