510(k) K260254

Enbio PRO by Enbio Group AG — Product Code FLE

K260254 is an FDA 510(k) premarket notification submitted by Enbio Group AG for the device "Enbio PRO". The FDA issued a decision of Substantially Equivalent on February 26, 2026. The device falls under product code FLE (Sterilizer, Steam), a Class II device regulated under 21 CFR 880.6880. Enbio Group AG has at least 2 other 510(k) clearances on record.