FDA 510(k)

NanoKnife Generator (H78720300351US0)

Número K: K253198 · 2026-03-24

Data da decisão2026-03-24

Código do produtoOAB

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

NanoKnife Generator (H78720300351US0) is the device name listed in this FDA 510(k) record. The listed applicant is Angiodynamics. It received FDA 510(k) clearance on 2026-03-24 under 510(k) number K253198. The device is classified under product code OAB. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the NanoKnife Generator (H78720300351US0)?

NanoKnife Generator (H78720300351US0) is a medical device that received FDA 510(k) clearance on 2026-03-24. The listed applicant is Angiodynamics. The 510(k) number is K253198.

When did NanoKnife Generator (H78720300351US0) receive FDA 510(k) clearance?

NanoKnife Generator (H78720300351US0) received FDA 510(k) clearance on 2026-03-24, under 510(k) number K253198.

Who is the listed applicant for NanoKnife Generator (H78720300351US0)?

The FDA 510(k) record lists Angiodynamics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NanoKnife Generator (H78720300351US0)?

The FDA product code for NanoKnife Generator (H78720300351US0) is OAB.

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Fonte oficial

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