FDA 510(k)

Axon Therapy

K-Number: K233364 · 2024-01-10

Decision Date2024-01-10

Product CodeQPL

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

Axon Therapy is the device name listed in this FDA 510(k) record. The listed applicant is Neuralace Medical, Inc.. It received FDA 510(k) clearance on 2024-01-10 under 510(k) number K233364. The device is classified under product code QPL. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Axon Therapy?

Axon Therapy is a medical device that received FDA 510(k) clearance on 2024-01-10. The listed applicant is Neuralace Medical, Inc.. The 510(k) number is K233364.

When did Axon Therapy receive FDA 510(k) clearance?

Axon Therapy received FDA 510(k) clearance on 2024-01-10, under 510(k) number K233364.

Who is the listed applicant for Axon Therapy?

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

What is the FDA product code for Axon Therapy?

The FDA product code for Axon Therapy is QPL.

Other records listing Neuralace Medical, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K210021Axon Therapy

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.