About This 510(k) Submission
K241734 is an FDA 510(k) clearance for the Wellead? Hydrophilic Intermittent Catheter Ready to Use; Wellead? Hydrophilic Intermittent Catheter Compact, a Catheter, Urethral (Class II — Special Controls, product code GBM), submitted by Well Lead Medical Co., Ltd. (Guangzhou, CN). The FDA issued a Cleared decision on March 5, 2025, 261 days after receiving the submission on June 17, 2024. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5130.