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FDA 510(k)

medXion NEXUS

K-Number: K253935 · 2026-05-15

ApplicantmedXion Technologies, Inc.
Decision Date2026-05-15
Product CodeOAS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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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Official Source

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