BCI-100 FECAL INCONTINENCE SYSTEM

BCI-100 FECAL INCONTINENCE SYSTEM is an FDA 510(k)-cleared medical device (K904646) manufactured by Biocare Intl.. 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 March 18, 1991. Regulation: 8.