ClearanceBrief
510(k) K233884 · OAB Low Energy Direct Current Thermal Ablation System

INUMI™ Flex Needle

ApplicantGalvanize Therapeutics, Inc., Redwood City CA, US
DecisionSubstantially Equivalent, May 22, 2024
ReceivedDec 8, 2023
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K233884

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.