510(k) K243228

Flexi-Seal AIR (with ENFit Connector) by Convatec — Product Code KNT

K243228 is an FDA 510(k) premarket notification submitted by Convatec for the device "Flexi-Seal AIR (with ENFit Connector)". The FDA issued a decision of Substantially Equivalent on March 28, 2025. The device falls under product code KNT (Tubes, Gastrointestinal (And Accessories)), a Class II device regulated under 21 CFR 876.5980. Convatec has at least 10 other 510(k) clearances on record.