INDWELLING FECAL MANAGEMENT SYSTEM-NON-STERILE

INDWELLING FECAL MANAGEMENT SYSTEM-NON-STERILE is an FDA 510(k)-cleared medical device (K023344) 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 November 5, 2002. Regulation: 8.