510(k) K970602

VAGINAL 2 ELECTRODE STIMULATION/EMG PROBE-SMALL by Hollister, Inc. — Product Code KPI

K970602 is an FDA 510(k) premarket notification submitted by Hollister, Inc. for the device "VAGINAL 2 ELECTRODE STIMULATION/EMG PROBE-SMALL". The FDA issued a decision of Substantially Equivalent on April 15, 1997. 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.