FDA 510(k)

Nalu Neurostimulation System for Peripheral Nerve Stimulation

N.º K: K232415 · 2024-08-21

SolicitanteBoston Scientific Neuromodulation

Fecha de decisión2024-08-21

Código de productoGZF

Comité asesorNE

DecisiónSubstantially Equivalent

Resumen del dispositivo

Nalu Neurostimulation System for Peripheral Nerve Stimulation is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Neuromodulation. It received FDA 510(k) clearance on 2024-08-21 under 510(k) number K232415. The device is classified under product code GZF. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Nalu Neurostimulation System for Peripheral Nerve Stimulation?

Nalu Neurostimulation System for Peripheral Nerve Stimulation is a medical device that received FDA 510(k) clearance on 2024-08-21. The listed applicant is Boston Scientific Neuromodulation. The 510(k) number is K232415.

When did Nalu Neurostimulation System for Peripheral Nerve Stimulation receive FDA 510(k) clearance?

Nalu Neurostimulation System for Peripheral Nerve Stimulation received FDA 510(k) clearance on 2024-08-21, under 510(k) number K232415.

Who is the listed applicant for Nalu Neurostimulation System for Peripheral Nerve Stimulation?

The FDA 510(k) record lists Boston Scientific Neuromodulation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Nalu Neurostimulation System for Peripheral Nerve Stimulation?

The FDA product code for Nalu Neurostimulation System for Peripheral Nerve Stimulation is GZF.

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

Otros registros que enlistan a Boston Scientific Neuromodulation como solicitante

K233801Nalu Neurostimulation System for Spinal Cord Stimulation; Nalu Neurostimulation System for Peripheral Nerve Stimulation K221376Nalu Neurostimulation System K203547Nalu Neurostimulation System K202274Kit de Neuroestimulación Nalu (lnte:gmted 40 em: Single 8/Dual 8), Kit de Neuroestimulación Nalu (Ported, 2 em: Single 8/Dual8), Generador de Pulsos Implantable Nalu Dual 8 Ported con 40 ern Kil, Kits de PruebaJExtension Lead de 40 cm/ 60 cm/60 em, Kits de Paciente y kits de repuestos varios K201618Nalu Neurostimulation SCS system K190960Nalu Lead Blank (50cm)

Ver todos los 9 dispositivos →

Dispositivos relacionados (Código: GZF)

K253877StimTrial Neuromodulation SystemBioventus, LLC K243782StimTrial Neuromodulation SystemBioventus, LLC K243678TalisMann Neuromodulation SystemBioventus, LLC K233162Freedom Peripheral Nerve Stimulator (PNS) SystemCuronix K221303Neuspera Nuity SystemNeuspera Medical, Inc.K211965StimRouter Neuromodulation SystemBioness, Inc.

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.