510(k) K221400

hygh-tec drainage by Creative Balloons GmbH — Product Code KNT

K221400 is an FDA 510(k) premarket notification submitted by Creative Balloons GmbH for the device "hygh-tec drainage". The FDA issued a decision of Substantially Equivalent on February 9, 2023. The device falls under product code KNT (Tubes, Gastrointestinal (And Accessories)), a Class II device regulated under 21 CFR 876.5980.