ClearanceBrief
510(k) K231061 ยท GEX Powered Laser Surgical Instrument

NeuroBlate System

ApplicantMonteris Medical,, Minnetonka MN, US
DecisionSubstantially Equivalent, Dec 8, 2023
ReceivedApr 13, 2023
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K231061

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.