ClearanceBrief
510(k) K240297 · OAB Low Energy Direct Current Thermal Ablation System

Canady Helios Cold Plasma™ XL-1000CP™ Ablation System (XL-1000CPSYS)

ApplicantUs Medical Innovations, LLC, Tacoma Park MD, US
DecisionSubstantially Equivalent, May 3, 2024
ReceivedFeb 1, 2024
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K240297

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.