FDA 510(k)

CIONIC NEURAL SLEEVE (NS-200)

N.º K: K243828 · 2025-05-02

Fecha de decisión2025-05-02

Código de productoGZI

Comité asesorNE

DecisiónSubstantially Equivalent

Resumen del 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.

Preguntas frecuentes

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.

Ensayos clínicos relacionados

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Dispositivos relacionados (Código: GZI)

K242704Synchrony (20-3000)Synapse Biomedical, Inc.K240632Neuvotion NeuStim NN-01Neuvotion, Inc.K233006MyndMove, MyndMove 2.0Myndtec, Inc.K230997EvoWalk 1.0 SystemEvolution Devices, Inc.K221823Cionic Neural Sleeve NS-100Cionic K213925MyoCycle MC-2 (Home / Home + / Pro / Pro +)Myolyn, LLC

Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.