510(k) K253198 ยท OAB Low Energy Direct Current Thermal Ablation System
NanoKnife Generator (H78720300351US0)
| Applicant | Angiodynamics, Marlborough MA, US |
| Decision | Substantially Equivalent, Mar 24, 2026 |
| Received | Sep 26, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253198
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.