Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Axon Therapy

K-Number: K210021 · 2021-06-11

Decision Date2021-06-11
Product CodeQPL
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Axon Therapy is a medical device manufactured by Neuralace Medical, Inc.. It received FDA 510(k) clearance on 2021-06-11 under approval number K210021. 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 2021-06-11. It is manufactured by Neuralace Medical, Inc.. The 510(k) number is K210021.

When was Axon Therapy approved by the FDA?

Axon Therapy received FDA 510(k) clearance on 2021-06-11, under approval number K210021.

What company makes Axon Therapy?

Axon Therapy is manufactured by Neuralace Medical, Inc..

What is the FDA product code for Axon Therapy?

The FDA product code for Axon Therapy is QPL.

Other Devices by Neuralace Medical, Inc.

Related Devices (Code: QPL)

Official Source

View on FDA Database →

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