510(k) K253846

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) by Hangzhou Ruidi Biotechnology , Ltd. — Product Code OAB

K253846 is an FDA 510(k) premarket notification submitted by Hangzhou Ruidi Biotechnology , Ltd. for the device "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)". The FDA issued a decision of Substantially Equivalent on August 12, 2026. The device falls under product code OAB (Low Energy Direct Current Thermal Ablation System), a Class II device regulated under 21 CFR 878.4400.