FDA 510(k)

Nerve Capping Device

Número K: K152684 · 2016-01-13

Data da decisão2016-01-13

Código do produtoJXI

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Nerve Capping Device is the device name listed in this FDA 510(k) record. The listed applicant is Polyganics Innovations BV. It received FDA 510(k) clearance on 2016-01-13 under 510(k) number K152684. The device is classified under product code JXI. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Nerve Capping Device?

Nerve Capping Device is a medical device that received FDA 510(k) clearance on 2016-01-13. The listed applicant is Polyganics Innovations BV. The 510(k) number is K152684.

When did Nerve Capping Device receive FDA 510(k) clearance?

Nerve Capping Device received FDA 510(k) clearance on 2016-01-13, under 510(k) number K152684.

Who is the listed applicant for Nerve Capping Device?

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

What is the FDA product code for Nerve Capping Device?

The FDA product code for Nerve Capping Device is JXI.

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Dispositivos Relacionados (Código: JXI)

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