FDA 510(k)

StimQ Peripheral Nerve Stimulator (PNS) System

Номер K: K152178 · 2016-03-11

ЗаявительStimq, LLC

Дата решения2016-03-11

Код продуктаGZF

Консультативный комитетNE

РешениеSubstantially Equivalent

Описание устройства

StimQ Peripheral Nerve Stimulator (PNS) System is the device name listed in this FDA 510(k) record. The listed applicant is Stimq, LLC. It received FDA 510(k) clearance on 2016-03-11 under 510(k) number K152178. 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 StimQ Peripheral Nerve Stimulator (PNS) System?

StimQ Peripheral Nerve Stimulator (PNS) System is a medical device that received FDA 510(k) clearance on 2016-03-11. The listed applicant is Stimq, LLC. The 510(k) number is K152178.

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

StimQ Peripheral Nerve Stimulator (PNS) System received FDA 510(k) clearance on 2016-03-11, under 510(k) number K152178.

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

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

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

The FDA product code for StimQ 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 K233162Freedom Peripheral Nerve Stimulator (PNS) SystemCuronix K221303Neuspera Nuity SystemNeuspera Medical, Inc.

Официальный источник

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