FDA 510(k)

NeuroSpan Bridge

Número K: K253363 · 2026-01-17

RequerenteAuxilium Biotechnologies, Inc.

Data da decisão2026-01-17

Código do produtoJXI

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

NeuroSpan Bridge is the device name listed in this FDA 510(k) record. The listed applicant is Auxilium Biotechnologies, Inc.. It received FDA 510(k) clearance on 2026-01-17 under 510(k) number K253363. 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 NeuroSpan Bridge?

NeuroSpan Bridge is a medical device that received FDA 510(k) clearance on 2026-01-17. The listed applicant is Auxilium Biotechnologies, Inc.. The 510(k) number is K253363.

When did NeuroSpan Bridge receive FDA 510(k) clearance?

NeuroSpan Bridge received FDA 510(k) clearance on 2026-01-17, under 510(k) number K253363.

Who is the listed applicant for NeuroSpan Bridge?

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

What is the FDA product code for NeuroSpan Bridge?

The FDA product code for NeuroSpan Bridge is JXI.

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