510(k) K253198

NanoKnife Generator (H78720300351US0) by Angiodynamics — Product Code OAB

K253198 is an FDA 510(k) premarket notification submitted by Angiodynamics for the device "NanoKnife Generator (H78720300351US0)". The FDA issued a decision of Substantially Equivalent on March 24, 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. Angiodynamics has at least 10 other 510(k) clearances on record.