ClearanceBrief
510(k) K260254 ยท FLE Sterilizer, Steam

Enbio PRO

ApplicantEnbio Group AG, Oensingen, CH
DecisionSubstantially Equivalent, Feb 26, 2026
ReceivedJan 27, 2026
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K260254

No recall in the FDA data names this 510(k).

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.