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FDA 510(k)

Nalu Neurostimulation System

K-Number: K203547 · 2021-03-25

ApplicantBoston Scientific Neuromodulation
Decision Date2021-03-25
Product CodeGZB
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Nalu Neurostimulation 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 2021-03-25 under 510(k) number K203547. The device is classified under product code GZB. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Nalu Neurostimulation System?

Nalu Neurostimulation System is a medical device that received FDA 510(k) clearance on 2021-03-25. The listed applicant is Boston Scientific Neuromodulation. The 510(k) number is K203547.

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

Nalu Neurostimulation System received FDA 510(k) clearance on 2021-03-25, under 510(k) number K203547.

Who is the listed applicant for Nalu Neurostimulation 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 System?

The FDA product code for Nalu Neurostimulation System is GZB.

Other records listing Boston Scientific Neuromodulation as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251247GX1 Radiofrequency Generator Kit (RFG-X1-120V); GX1 Radiofrequency Generator Kit (RFG-X1-220V); GX1 Radiofrequency Generator Kit (RFG-X1-240V); GX1 System Release Rest of World (GX1-SYS-ROW); GX1 Radiofrequency Generator (51779845-01); GX1 Radiofrequency Generator (51779845-02); GX1 Radiofrequency Generator (51779845-03)PMA P140004Prosthesis, spinous process spacer/plateK233801Nalu Neurostimulation System for Spinal Cord Stimulation; Nalu Neurostimulation System for Peripheral Nerve StimulationK232415Nalu Neurostimulation System for Peripheral Nerve StimulationK221376Nalu Neurostimulation SystemK202274Nalu Neurostimulation Kit (lnte:gmted 40 em: Single 8/Dual 8), Nalu Neurostimulation Kit (Ported, 2 em: Single 8/Dual8), Dual 8 Ported Nalu Implantable Pulse Generator with 40 ern Kil, 40 cm/ 60 cm/60 em TrialJExtension Lead Kits, Patient Kits and miscellaneous replacement kits

View all 11 devices →

Related Devices (Code: GZB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K233801Nalu Neurostimulation System for Spinal Cord Stimulation; Nalu Neurostimulation System for Peripheral Nerve StimulationBoston Scientific NeuromodulationK221376Nalu Neurostimulation SystemBoston Scientific NeuromodulationK202274Nalu Neurostimulation Kit (lnte:gmted 40 em: Single 8/Dual 8), Nalu Neurostimulation Kit (Ported, 2 em: Single 8/Dual8), Dual 8 Ported Nalu Implantable Pulse Generator with 40 ern Kil, 40 cm/ 60 cm/60 em TrialJExtension Lead Kits, Patient Kits and miscellaneous replacement kitsBoston Scientific NeuromodulationK201618Nalu Neurostimulation SCS systemBoston Scientific NeuromodulationK191466SandShark Injectable Anchor (SIA) SystemStimwave Technologies, Inc.K190960Nalu Lead Blank (50cm)Boston Scientific Neuromodulation

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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