ClearanceBrief
510(k) K262315 ยท ONO Neurosurgical Laser With Mr Thermography

NeuroBlate System

ApplicantMonteris Medical, Minnetonka MN, US
DecisionSubstantially Equivalent, Sep 3, 2026
ReceivedJul 8, 2026
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K262315

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.