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FDA 510(k)

Nalu Neurostimulation System for Spinal Cord Stimulation; Nalu Neurostimulation System for Peripheral Nerve Stimulation

N.º K: K233801 · 2024-08-23

SolicitanteBoston Scientific Neuromodulation
Fecha de decisión2024-08-23
Código de productoGZB
Comité asesorNE
DecisiónSubstantially Equivalent

Resumen del dispositivo

Nalu Neurostimulation System for Spinal Cord Stimulation; 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 2024-08-23 under 510(k) number K233801. The device is classified under product code GZB. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Nalu Neurostimulation System for Spinal Cord Stimulation; Nalu Neurostimulation System for Peripheral Nerve Stimulation?

Nalu Neurostimulation System for Spinal Cord Stimulation; Nalu Neurostimulation System for Peripheral Nerve Stimulation is a medical device that received FDA 510(k) clearance on 2024-08-23. The listed applicant is Boston Scientific Neuromodulation. The 510(k) number is K233801.

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

Nalu Neurostimulation System for Spinal Cord Stimulation; Nalu Neurostimulation System for Peripheral Nerve Stimulation received FDA 510(k) clearance on 2024-08-23, under 510(k) number K233801.

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

The FDA product code for Nalu Neurostimulation System for Spinal Cord Stimulation; Nalu Neurostimulation System for Peripheral Nerve Stimulation is GZB.

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Otros registros que enlistan a Boston Scientific Neuromodulation como solicitante

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.

K232415Nalu Neurostimulation System for Peripheral Nerve StimulationK221376Nalu Neurostimulation SystemK203547Nalu Neurostimulation SystemK202274Kit 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 variosK201618Nalu Neurostimulation SCS systemK190960Nalu Lead Blank (50cm)

Ver todos los 9 dispositivos →

Dispositivos relacionados (Código: GZB)

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.

K221376Nalu Neurostimulation SystemBoston Scientific NeuromodulationK203547Nalu Neurostimulation SystemBoston Scientific NeuromodulationK202274Kit 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 variosBoston Scientific NeuromodulationK201618Nalu Neurostimulation SCS systemBoston Scientific NeuromodulationK191466SandShark Injectable Anchor (SIA) SystemStimwave Technologies, Inc.K190960Nalu Lead Blank (50cm)Boston Scientific Neuromodulation

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.

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