510(k) K231891

Virtue Male Sling System with Alexis Wound Retractor Convenience Kit by Coloplast — Product Code OTM

K231891 is an FDA 510(k) premarket notification submitted by Coloplast for the device "Virtue Male Sling System with Alexis Wound Retractor Convenience Kit". The FDA issued a decision of Substantially Equivalent (kit) on September 25, 2023. The device falls under product code OTM (Mesh, Surgical, For Stress Urinary Incontinence, Male), a Class II device regulated under 21 CFR 878.3300. Coloplast has at least 10 other 510(k) clearances on record.