15L Cycler Drainage Bag

15L Cycler Drainage Bag is an FDA 510(k)-cleared medical device (K214016) manufactured by Baxter Healthcare Corporation. 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 March 17, 2022. Regulation: 8.