FDA 510(k)

OWL RF INSULATED CANNULAE

Номер K: K170708 · 2017-06-27

Дата решения2017-06-27

Код продуктаGXI

Консультативный комитетNE

РешениеSubstantially Equivalent

Описание устройства

OWL RF INSULATED CANNULAE is the device name listed in this FDA 510(k) record. The listed applicant is Diros Technology, Inc.. It received FDA 510(k) clearance on 2017-06-27 under 510(k) number K170708. 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 OWL RF INSULATED CANNULAE?

OWL RF INSULATED CANNULAE is a medical device that received FDA 510(k) clearance on 2017-06-27. The listed applicant is Diros Technology, Inc.. The 510(k) number is K170708.

When did OWL RF INSULATED CANNULAE receive FDA 510(k) clearance?

OWL RF INSULATED CANNULAE received FDA 510(k) clearance on 2017-06-27, under 510(k) number K170708.

Who is the listed applicant for OWL RF INSULATED CANNULAE?

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

What is the FDA product code for OWL RF INSULATED CANNULAE?

The FDA product code for OWL RF INSULATED CANNULAE 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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