FDA 510(k)

Nalu Neurostimulation SCS system

Numéro K : K201618 · 2020-07-15

DemandeurBoston Scientific Neuromodulation

Date de décision2020-07-15

Code produitGZB

Comité consultatifNE

DécisionSubstantially Equivalent

Résumé du dispositif

Nalu Neurostimulation SCS system 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 2020-07-15 under 510(k) number K201618. The device is classified under product code GZB. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Nalu Neurostimulation SCS system?

Nalu Neurostimulation SCS system is a medical device that received FDA 510(k) clearance on 2020-07-15. The listed applicant is Boston Scientific Neuromodulation. The 510(k) number is K201618.

When did Nalu Neurostimulation SCS system receive FDA 510(k) clearance?

Nalu Neurostimulation SCS system received FDA 510(k) clearance on 2020-07-15, under 510(k) number K201618.

Who is the listed applicant for Nalu Neurostimulation SCS system?

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 SCS system?

The FDA product code for Nalu Neurostimulation SCS system is GZB.

Essais cliniques associés

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Autres dossiers indiquant Boston Scientific Neuromodulation en tant que demandeur

K233801Nalu Neurostimulation System for Spinal Cord Stimulation; Nalu Neurostimulation System for Peripheral Nerve Stimulation K232415Nalu Neurostimulation System for Peripheral Nerve Stimulation K221376Nalu Neurostimulation System K203547Nalu Neurostimulation System K202274Kit de Neurostimulation Nalu (lnte:gmted 40 em: Unique 8/Dual 8), Kit de Neurostimulation Nalu (Porté, 2 em: Unique 8/Dual8), Générateur de Pulsations Implantable Nalu Dual 8 Porté avec 40 ern Kil, Kits de EssaiJExtension Lead de 40 cm/ 60 cm/60 em, Kits de Patient et kits de remplacement divers K190960Cartouche de Conducteur Nalu (50cm)

Voir tous les 9 dispositifs →

Dispositifs connexes (Code : GZB)

K233801Nalu Neurostimulation System for Spinal Cord Stimulation; Nalu Neurostimulation System for Peripheral Nerve StimulationBoston Scientific Neuromodulation K221376Nalu Neurostimulation SystemBoston Scientific Neuromodulation K203547Nalu Neurostimulation SystemBoston Scientific Neuromodulation K202274Kit de Neurostimulation Nalu (lnte:gmted 40 em: Unique 8/Dual 8), Kit de Neurostimulation Nalu (Porté, 2 em: Unique 8/Dual8), Générateur de Pulsations Implantable Nalu Dual 8 Porté avec 40 ern Kil, Kits de EssaiJExtension Lead de 40 cm/ 60 cm/60 em, Kits de Patient et kits de remplacement diversBoston Scientific Neuromodulation K191466SandShark Injectable Anchor (SIA) SystemStimwave Technologies, Inc.K190960Cartouche de Conducteur Nalu (50cm)Boston Scientific Neuromodulation

Source officielle

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