FDA 510(k)

Illuminated Mediastinal Access Port

Номер K: K160171 · 2016-02-26

Дата решения2016-02-26

Код продуктаEWY

Консультативный комитетEN

РешениеSubstantially Equivalent

Описание устройства

Illuminated Mediastinal Access Port is the device name listed in this FDA 510(k) record. The listed applicant is Aegis Surgical, Ltd.. It received FDA 510(k) clearance on 2016-02-26 under 510(k) number K160171. The device is classified under product code EWY. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the Illuminated Mediastinal Access Port?

Illuminated Mediastinal Access Port is a medical device that received FDA 510(k) clearance on 2016-02-26. The listed applicant is Aegis Surgical, Ltd.. The 510(k) number is K160171.

When did Illuminated Mediastinal Access Port receive FDA 510(k) clearance?

Illuminated Mediastinal Access Port received FDA 510(k) clearance on 2016-02-26, under 510(k) number K160171.

Who is the listed applicant for Illuminated Mediastinal Access Port?

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

What is the FDA product code for Illuminated Mediastinal Access Port?

The FDA product code for Illuminated Mediastinal Access Port is EWY.

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: EWY)

K260003KARL STORZ Mediastinoscopes and InstrumentsKarl Storz SE & CO. KG K213194HD MediastinoscopeKarl Storz Endoscopy America, Inc.K202272HD MediastinoscopeKarl Storz Endoscopy America, Inc.K170757Aegis Transit SystemBoston-Biomedical Associates

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