FDA 510(k)

Freedom Peripheral Nerve Stimulator (PNS) System

Номер K: K233162 · 2024-06-20

ЗаявительCuronix

Дата решения2024-06-20

Код продуктаGZF

Консультативный комитетNE

РешениеSubstantially Equivalent

Описание устройства

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.

Часто задаваемые вопросы

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.

Связанные клинические исследования

Связанные записи сопоставляются автоматически на основании названий, кодов продукции или иных метаданных. Сопоставление не подтверждает клиническую, научную, корпоративную или регуляторную связь; ознакомьтесь с официальными источниками по ссылкам.

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Связанные устройства (Код: GZF)

K253877StimTrial Neuromodulation SystemBioventus, LLC K243782StimTrial Neuromodulation SystemBioventus, LLC K243678TalisMann Neuromodulation SystemBioventus, LLC K232415Nalu Neurostimulation System for Peripheral Nerve StimulationBoston Scientific Neuromodulation K221303Neuspera Nuity SystemNeuspera Medical, Inc.K211965StimRouter Neuromodulation SystemBioness, Inc.

Официальный источник

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