510(k) K212871 ยท OAB Low Energy Direct Current Thermal Ablation System
Aliya(TM) System, Aliya(TM) Generator, Aliya(TM) Needle, Aliya(TM) Electrode
| Applicant | Galvanize Therapeutics, Inc., San Carlos CA, US |
| Decision | Substantially Equivalent, Jun 17, 2022 |
| Received | Sep 9, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K212871
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.