510(k) K253826 · OAB Low Energy Direct Current Thermal Ablation System
Aliya® EX System; Aliya® EX Generator; Aliya® Needle; Aliya® Electrode; INUMI Flex Needle
| Applicant | Galvanize Therapeutics, Inc., Redwood City CA, US |
| Decision | Substantially Equivalent, May 7, 2026 |
| Received | Dec 1, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253826
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.