510(k) K863227

COOK-VPI CONTINENCE CUFF by Cook Urological, Inc. — Product Code FHA

K863227 is an FDA 510(k) premarket notification submitted by Cook Urological, Inc. for the device "COOK-VPI CONTINENCE CUFF". The FDA issued a decision of Substantially Equivalent on February 3, 1987. The device falls under product code FHA (Clamp, Penile), a Class I device regulated under 21 CFR 876.5160. Cook Urological, Inc. has at least 10 other 510(k) clearances on record.