ClearanceBrief
510(k) K222983 ยท GEX Powered Laser Surgical Instrument

NeuroBlate Fusion-S Software V3.17

ApplicantMonteris Medical,, Minnetonka MN, US
DecisionSubstantially Equivalent, Mar 15, 2023
ReceivedSep 28, 2022
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K222983

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.