About This 510(k) Submission
K972887 is an FDA 510(k) clearance for the MEDLINE PREMIUM LEG BAG, MEDLINE FABRIC BAC LEG BAG, MEDLINE URINARY LEG BAG, a Collector, Urine, (and Accessories) For Indwelling Catheter (Class II — Special Controls, product code KNX), submitted by Medline Industries, Inc. (Mundelein, US). The FDA issued a Cleared decision on December 11, 1997, 128 days after receiving the submission on August 5, 1997. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5250.