510(k) K101297

VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM MODEL 50020 by Coloplast A/S — Product Code OTM

K101297 is an FDA 510(k) premarket notification submitted by Coloplast A/S for the device "VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM MODEL 50020". The FDA issued a decision of Substantially Equivalent on June 3, 2010. 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.