INSTAFLO BOWEL CATHETER SYSTEM KIT

INSTAFLO BOWEL CATHETER SYSTEM KIT is an FDA 510(k)-cleared medical device (K100273) manufactured by Hollister, Inc.. 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 April 21, 2010. Regulation: 8.