About This 510(k) Submission
K083153 is an FDA 510(k) clearance for the ACTIFLO INDWELLING BOWEL CATHETER SYSTEM KIT, MODELS: 32004, 32005, 32006, 32007, a Tubes, Gastrointestinal (and Accessories) (Class II — Special Controls, product code KNT), submitted by Hollister, Inc. (Libertyville, US). The FDA issued a Cleared decision on February 4, 2009, 103 days after receiving the submission on October 24, 2008. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5980.