510(k) K013653

INCARE PRESSURE BIOFEEDBACK VAGINAL PRESSURE PROBE AND ANAL PRESSURE PROBE by Hollister, Inc. — Product Code HIR

K013653 is an FDA 510(k) premarket notification submitted by Hollister, Inc. for the device "INCARE PRESSURE BIOFEEDBACK VAGINAL PRESSURE PROBE AND ANAL PRESSURE PROBE". The FDA issued a decision of Substantially Equivalent on March 5, 2002. The device falls under product code HIR (Perineometer), a Class II device regulated under 21 CFR 884.1425. Hollister, Inc. has at least 10 other 510(k) clearances on record.