ClearanceBrief
510(k) K262235 · PGW Ear, Nose, And Throat Stereotaxic Instrument

ApexCut ™ Blade with Automated EM Tracking (187BL4012EM);ApexCut ™ Blade with Automated EM Tracking (187BL4040EM);ApexCut ™ Blade with Automated EM Tracking (187BL4060EM);ApexCut ™ Blade with Automated EM Tracking (187BL2975EM);ApexCut ™ Blade with Automated EM Tracking (187BL3590EM);ApexCut ™ Blade

ApplicantMedtronic Xomed, Inc., Jacksonville FL, US
DecisionSubstantially Equivalent, Sep 4, 2026
ReceivedJul 1, 2026
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K262235

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.