FDA 510(k)

SurgiMend PRS Meshed, Revize-X

Номер K: K171357 · 2017-06-07

ЗаявительIntegra Lifesciences Corporation (Owner of Tei Biosciences)

Дата решения2017-06-07

Код продуктаOXH

Консультативный комитетSU

РешениеSubstantially Equivalent

Описание устройства

SurgiMend PRS Meshed, Revize-X is the device name listed in this FDA 510(k) record. The listed applicant is Integra Lifesciences Corporation (Owner of Tei Biosciences). It received FDA 510(k) clearance on 2017-06-07 under 510(k) number K171357. The device is classified under product code OXH. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the SurgiMend PRS Meshed, Revize-X?

SurgiMend PRS Meshed, Revize-X is a medical device that received FDA 510(k) clearance on 2017-06-07. The listed applicant is Integra Lifesciences Corporation (Owner of Tei Biosciences). The 510(k) number is K171357.

When did SurgiMend PRS Meshed, Revize-X receive FDA 510(k) clearance?

SurgiMend PRS Meshed, Revize-X received FDA 510(k) clearance on 2017-06-07, under 510(k) number K171357.

Who is the listed applicant for SurgiMend PRS Meshed, Revize-X?

The FDA 510(k) record lists Integra Lifesciences Corporation (Owner of Tei Biosciences) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SurgiMend PRS Meshed, Revize-X?

The FDA product code for SurgiMend PRS Meshed, Revize-X is OXH.

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: OXH)

K251844Kerecis SurgiBind (50241)Kerecis Limited K202430Kerecis ReconstructKerecis Limited K160400Miromatrix Biological MeshMiromatrix Medical, Inc.

Официальный источник

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