510(k) K050483

EVADRI BLADDER CONTROL SYSTEMS by Hollister, Inc. — Product Code KPI

K050483 is an FDA 510(k) premarket notification submitted by Hollister, Inc. for the device "EVADRI BLADDER CONTROL SYSTEMS". The FDA issued a decision of Substantially Equivalent on April 12, 2005. The device falls under product code KPI (Stimulator, Electrical, Non-Implantable, For Incontinence), a Class II device regulated under 21 CFR 876.5320. Hollister, Inc. has at least 10 other 510(k) clearances on record.