FDA 510(k)

CIONIC NEURAL SLEEVE (NS-200)

Número K: K243828 · 2025-05-02

Data da decisão2025-05-02

Código do produtoGZI

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

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

Perguntas frequentes

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. The listed applicant is Cionic, Inc.. The 510(k) number is K243828.

When did CIONIC NEURAL SLEEVE (NS-200) receive FDA 510(k) clearance?

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

Who is the listed applicant for CIONIC NEURAL SLEEVE (NS-200)?

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

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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