FDA 510(k)

medXion NEXUS

Número K: K253935 · 2026-05-15

Data da decisão2026-05-15

Código do produtoOAS

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

medXion NEXUS is the device name listed in this FDA 510(k) record. The listed applicant is medXion Technologies, Inc.. It received FDA 510(k) clearance on 2026-05-15 under 510(k) number K253935. The device is classified under product code OAS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the medXion NEXUS?

medXion NEXUS is a medical device that received FDA 510(k) clearance on 2026-05-15. The listed applicant is medXion Technologies, Inc.. The 510(k) number is K253935.

When did medXion NEXUS receive FDA 510(k) clearance?

medXion NEXUS received FDA 510(k) clearance on 2026-05-15, under 510(k) number K253935.

Who is the listed applicant for medXion NEXUS?

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

What is the FDA product code for medXion NEXUS?

The FDA product code for medXion NEXUS is OAS.

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