FDA 510(k)

Vesta RF Cannula

Номер K: K190259 · 2020-02-07

ЗаявительBiomerics

Дата решения2020-02-07

Код продуктаGXI

Консультативный комитетNE

РешениеSubstantially Equivalent

Описание устройства

Vesta RF Cannula is the device name listed in this FDA 510(k) record. The listed applicant is Biomerics. It received FDA 510(k) clearance on 2020-02-07 under 510(k) number K190259. The device is classified under product code GXI. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the Vesta RF Cannula?

Vesta RF Cannula is a medical device that received FDA 510(k) clearance on 2020-02-07. The listed applicant is Biomerics. The 510(k) number is K190259.

When did Vesta RF Cannula receive FDA 510(k) clearance?

Vesta RF Cannula received FDA 510(k) clearance on 2020-02-07, under 510(k) number K190259.

Who is the listed applicant for Vesta RF Cannula?

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

What is the FDA product code for Vesta RF Cannula?

The FDA product code for Vesta RF Cannula is GXI.

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: GXI)

K253907Disposable Radiofrequency CannulaABBOTT MEDICAL K251802STAR RF Ablation SystemMerit Medical Systems, Inc.K251243OneRF Trigeminal Nerve Radiofrequency ProbesNeuroone Medical Technologies Corp.K242841Disposable RF Electrode (RFDE-5/RFDE-10/RFDE-15/RFDE-20)ABBOTT MEDICAL K250213OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Single Kit); OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Dual Kit)Stryker Instruments K241367RF CannulaShanghai Samedical & Plastic Instruments Co., Ltd.

Официальный источник

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