510(k) K111881

VIRTUE MALE SLING SYSTEM AND ALEXIS(R) WOUND RETRACTOR KIT by Coloplast A/S — Product Code OTM

K111881 is an FDA 510(k) premarket notification submitted by Coloplast A/S for the device "VIRTUE MALE SLING SYSTEM AND ALEXIS(R) WOUND RETRACTOR KIT". The FDA issued a decision of Substantially Equivalent on August 17, 2011. 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 A/S has at least 10 other 510(k) clearances on record.