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FDA 510(k)

CIONIC NEURAL SLEEVE (NS-200)

K-Number: K243828 · 2025-05-02

ApplicantCionic, Inc.
Decision Date2025-05-02
Product CodeGZI
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

CIONIC NEURAL SLEEVE (NS-200) is a medical device manufactured by Cionic, Inc.. It received FDA 510(k) clearance on 2025-05-02 under approval number K243828. The device is classified under product code GZI. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CIONIC NEURAL SLEEVE (NS-200)?

CIONIC NEURAL SLEEVE (NS-200) is a medical device that received FDA 510(k) clearance on 2025-05-02. It is manufactured by Cionic, Inc.. The 510(k) number is K243828.

When was CIONIC NEURAL SLEEVE (NS-200) approved by the FDA?

CIONIC NEURAL SLEEVE (NS-200) received FDA 510(k) clearance on 2025-05-02, under approval number K243828.

What company makes CIONIC NEURAL SLEEVE (NS-200)?

CIONIC NEURAL SLEEVE (NS-200) is manufactured by Cionic, Inc..

What is the FDA product code for CIONIC NEURAL SLEEVE (NS-200)?

The FDA product code for CIONIC NEURAL SLEEVE (NS-200) is GZI.

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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.

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