FDA 510(k)

Nalu Neurostimulation System for Peripheral Nerve Stimulation

Número K: K232415 · 2024-08-21

RequerenteBoston Scientific Neuromodulation

Data da decisão2024-08-21

Código do produtoGZF

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do 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.

Perguntas frequentes

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.

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Outros registros que listam Boston Scientific Neuromodulation como candidato(a)

K233801Nalu Neurostimulation System for Spinal Cord Stimulation; Nalu Neurostimulation System for Peripheral Nerve Stimulation K221376Nalu Neurostimulation System K203547Nalu Neurostimulation System K202274Kit de Neuroestimulação Nalu (lnte:gmted 40 em: Single 8/Dual 8), Kit de Neuroestimulação Nalu (Portado, 2 em: Single 8/Dual8), Gerador de Pulsos Implantável Nalu Duplo 8 Portado com 40 ern Kil, Kits de Extensão de Cabos de Teste de 40 cm/ 60 cm/60 em, Kits de Paciente e kits de substituição diversos K201618Nalu Neurostimulation SCS system K190960Nalu Lead Blank (50cm)

Ver todos os 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.

Fonte oficial

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