INDWELLING FECAL MANAGEMENT SYSTEM

INDWELLING FECAL MANAGEMENT SYSTEM is an FDA 510(k)-cleared medical device (K012113) manufactured by Bowel Management Systems, 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 May 2, 2002. Regulation: 8.