ClearanceBrief
510(k) K261266 · FMI Needle, Hypodermic, Single Lumen

MOWANA™ Auto Duo

ApplicantPENTAMASTER MEDIQ SDN BHD, Simpang Ampat, MY
DecisionSubstantially Equivalent, Sep 17, 2026
ReceivedApr 16, 2026
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K261266

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.