PENILE CONSTRICTOR RING

PENILE CONSTRICTOR RING is an FDA 510(k)-cleared medical device (K001859) manufactured by Basic Solutions, LLC. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 10, 2001. Regulation: 8.