510(k) K993721

UROSTYM BIOFEEDBACK AND STIMULATION ANAL/RECTAL PROBES by Laborie Medical Tech Corp. — Product Code KPI

K993721 is an FDA 510(k) premarket notification submitted by Laborie Medical Tech Corp. for the device "UROSTYM BIOFEEDBACK AND STIMULATION ANAL/RECTAL PROBES". The FDA issued a decision of Substantially Equivalent on November 29, 1999. The device falls under product code KPI (Stimulator, Electrical, Non-Implantable, For Incontinence), a Class II device regulated under 21 CFR 876.5320. Laborie Medical Tech Corp. has at least 5 other 510(k) clearances on record.