510(k) K061333

URGENT PC NEUROMODULATION SYSTEM, MODELS UPC200-A AND UPC250-12 by Uroplasty, Inc. — Product Code NAM

K061333 is an FDA 510(k) premarket notification submitted by Uroplasty, Inc. for the device "URGENT PC NEUROMODULATION SYSTEM, MODELS UPC200-A AND UPC250-12". The FDA issued a decision of Substantially Equivalent on July 3, 2006. The device falls under product code NAM (Stimulator, Peripheral Nerve, Non-Implanted, For Urinary Incontinence), a Class II device regulated under 21 CFR 876.5310. Uroplasty, Inc. has at least 7 other 510(k) clearances on record.