510(k) K990456

ANAL 2 ELECTRODE STIMULATION/EMG PROBE - W/STOP by Hollister, Inc. — Product Code KPI

K990456 is an FDA 510(k) premarket notification submitted by Hollister, Inc. for the device "ANAL 2 ELECTRODE STIMULATION/EMG PROBE - W/STOP". The FDA issued a decision of Substantially Equivalent on March 25, 1999. 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.