510(k) K242336

hygh-tec Drainage II by Amb Medtec — Product Code KNT

K242336 is an FDA 510(k) premarket notification submitted by Amb Medtec for the device "hygh-tec Drainage II". The FDA issued a decision of Substantially Equivalent on January 17, 2025. The device falls under product code KNT (Tubes, Gastrointestinal (And Accessories)), a Class II device regulated under 21 CFR 876.5980.