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FDA 510(k)

Freedom Peripheral Nerve Stimulator (PNS) System

K-Number: K233162 · 2024-06-20

ApplicantCuronix
Decision Date2024-06-20
Product CodeGZF
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Freedom Peripheral Nerve Stimulator (PNS) System is the device name listed in this FDA 510(k) record. The listed applicant is Curonix. It received FDA 510(k) clearance on 2024-06-20 under 510(k) number K233162. 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 Freedom Peripheral Nerve Stimulator (PNS) System?

Freedom Peripheral Nerve Stimulator (PNS) System is a medical device that received FDA 510(k) clearance on 2024-06-20. The listed applicant is Curonix. The 510(k) number is K233162.

When did Freedom Peripheral Nerve Stimulator (PNS) System receive FDA 510(k) clearance?

Freedom Peripheral Nerve Stimulator (PNS) System received FDA 510(k) clearance on 2024-06-20, under 510(k) number K233162.

Who is the listed applicant for Freedom Peripheral Nerve Stimulator (PNS) System?

The FDA 510(k) record lists Curonix as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Freedom Peripheral Nerve Stimulator (PNS) System?

The FDA product code for Freedom Peripheral Nerve Stimulator (PNS) System is GZF.

Related Devices (Code: GZF)

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.

K243782StimTrial Neuromodulation SystemBioventus, LLCK243678TalisMann Neuromodulation SystemBioventus, LLCK232415Nalu Neurostimulation System for Peripheral Nerve StimulationBoston Scientific NeuromodulationK221303Neuspera 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.

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