K103254 is an FDA 510(k) clearance for the PERISTEEN ANAL IRRIGATION SYSTEM, IRRIGATION ACCESSORY UNIT, IRRIGATION RECTAL CATHETER, SYSTEM STRAP, IRRIGATION TUBE, a Tubes, Gastrointestinal (and Accessories) (Class II — Special Controls, product code KNT), submitted by Coloplast A/S (Plymouth, US). The FDA issued a Cleared decision on January 31, 2011, 89 days after receiving the submission on November 3, 2010. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5980.