510(k) K971541

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

K971541 is an FDA 510(k) premarket notification submitted by Hollister, Inc. for the device "VAGINAL 2 ELECTRODE STIMULATION/EMG PROBE - TAMPON". The FDA issued a decision of Substantially Equivalent on June 25, 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.