About This 510(k) Submission
K231891 is an FDA 510(k) clearance for the Virtue Male Sling System with Alexis Wound Retractor Convenience Kit, a Mesh, Surgical, For Stress Urinary Incontinence, Male (Class II — Special Controls, product code OTM), submitted by Coloplast (Plymouth, US). The FDA issued a Cleared decision on September 25, 2023, 90 days after receiving the submission on June 27, 2023. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 878.3300.