FDA 510(k)

Nalu Neurostimulation System for Peripheral Nerve Stimulation

K-Number: K232415 · 2024-08-21

ApplicantBoston Scientific Neuromodulation

Decision Date2024-08-21

Product CodeGZF

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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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Other records listing Boston Scientific Neuromodulation as applicant

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Related Devices (Code: GZF)

K243782StimTrial Neuromodulation SystemBioventus, LLC K243678TalisMann Neuromodulation SystemBioventus, LLC K233162Freedom Peripheral Nerve Stimulator (PNS) SystemCuronix K221303Neuspera Nuity SystemNeuspera Medical, Inc.K211965StimRouter Neuromodulation SystemBioness, Inc.K202781Neuspera Neurostimulation System (NNS)Neuspera Medical, Inc.

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.