510(k) K113496

VIRTURE MALE SLING SYSTEM WITH ALEXIS WOUND RETRACTOR CONVENIENCE KIT by Coloplast A/S — Product Code OTM

K113496 is an FDA 510(k) premarket notification submitted by Coloplast A/S for the device "VIRTURE MALE SLING SYSTEM WITH ALEXIS WOUND RETRACTOR CONVENIENCE KIT". The FDA issued a decision of Substantially Equivalent on February 14, 2012. 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.