510(k) K253846 ยท OAB Low Energy Direct Current Thermal Ablation System
Steep Pulse Ablation Instrument (including Disposable Sterile Steep Pulse Probe) (SPA-C02); Disposable Sterile Steep Pulse Probe (NPA-DJ01); Probe connection line (NPA-LX-02)
| Applicant | Hangzhou Ruidi Biotechnology , Ltd., Hangzhou, CN |
| Decision | Substantially Equivalent, Aug 12, 2026 |
| Received | Dec 2, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253846
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.