FDA 510(k)

Neuralytix iD3 System (NTX-9001)

N.º K: K243636 · 2025-06-26

Fecha de decisión2025-06-26

Código de productoPDQ

Comité asesorEN

DecisiónSubstantially Equivalent

Resumen del dispositivo

Neuralytix iD3 System (NTX-9001) is the device name listed in this FDA 510(k) record. The listed applicant is Neuralytix, LLC. It received FDA 510(k) clearance on 2025-06-26 under 510(k) number K243636. The device is classified under product code PDQ. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Neuralytix iD3 System (NTX-9001)?

Neuralytix iD3 System (NTX-9001) is a medical device that received FDA 510(k) clearance on 2025-06-26. The listed applicant is Neuralytix, LLC. The 510(k) number is K243636.

When did Neuralytix iD3 System (NTX-9001) receive FDA 510(k) clearance?

Neuralytix iD3 System (NTX-9001) received FDA 510(k) clearance on 2025-06-26, under 510(k) number K243636.

Who is the listed applicant for Neuralytix iD3 System (NTX-9001)?

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

What is the FDA product code for Neuralytix iD3 System (NTX-9001)?

The FDA product code for Neuralytix iD3 System (NTX-9001) is PDQ.

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: PDQ)

K260992iD3 Nav Decompression Probe (NTX-9005); iD3 Ball Tip Stim Probe (NTX-9006); iD3 Nav Ball Tip Probe (NTX-9007)Neuralytix K253580Sterile Insulated Dilators, 5, 10, 16mm (MDT-0442S); Sterile, Insulated Dilator, 20mm (MDT-0469S)Tedan Surgical Innovations K223438TELIGEN System Peripheral Motor Nerve Stimulation IndicationsMedos International SARL K221821Instrumentos Accesorios IOM ATECAlphatec Spine, Inc.K220160PediGuard ThreadedSpineguard S.A.K203684Neurosign V4 Intraoperative Nerve MonitorMagstim Company, Ltd.

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.