FDA 510(k)

Evala Nerve Stimulator (EPNR002)

Número K: K253536 · 2026-02-27

Data da decisão2026-02-27

Código do produtoETN

Comité consultivoEN

DecisãoSubstantially Equivalent

Resumo do dispositivo

Evala Nerve Stimulator (EPNR002) is the device name listed in this FDA 510(k) record. The listed applicant is Epineuron Technologies, Inc.. It received FDA 510(k) clearance on 2026-02-27 under 510(k) number K253536. The device is classified under product code ETN. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Evala Nerve Stimulator (EPNR002)?

Evala Nerve Stimulator (EPNR002) is a medical device that received FDA 510(k) clearance on 2026-02-27. The listed applicant is Epineuron Technologies, Inc.. The 510(k) number is K253536.

When did Evala Nerve Stimulator (EPNR002) receive FDA 510(k) clearance?

Evala Nerve Stimulator (EPNR002) received FDA 510(k) clearance on 2026-02-27, under 510(k) number K253536.

Who is the listed applicant for Evala Nerve Stimulator (EPNR002)?

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

What is the FDA product code for Evala Nerve Stimulator (EPNR002)?

The FDA product code for Evala Nerve Stimulator (EPNR002) is ETN.

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