FDA 510(k)

Endoform Plastics and Reconstructive Matrix

Номер K: K162461 · 2016-12-20

ЗаявительAroa Biosurgery (Formerly Mesynthes Limited)

Дата решения2016-12-20

Код продуктаFTM

Консультативный комитетSU

РешениеSubstantially Equivalent

Описание устройства

Endoform Plastics and Reconstructive Matrix is the device name listed in this FDA 510(k) record. The listed applicant is Aroa Biosurgery (Formerly Mesynthes Limited). It received FDA 510(k) clearance on 2016-12-20 under 510(k) number K162461. The device is classified under product code FTM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the Endoform Plastics and Reconstructive Matrix?

Endoform Plastics and Reconstructive Matrix is a medical device that received FDA 510(k) clearance on 2016-12-20. The listed applicant is Aroa Biosurgery (Formerly Mesynthes Limited). The 510(k) number is K162461.

When did Endoform Plastics and Reconstructive Matrix receive FDA 510(k) clearance?

Endoform Plastics and Reconstructive Matrix received FDA 510(k) clearance on 2016-12-20, under 510(k) number K162461.

Who is the listed applicant for Endoform Plastics and Reconstructive Matrix?

The FDA 510(k) record lists Aroa Biosurgery (Formerly Mesynthes Limited) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Endoform Plastics and Reconstructive Matrix?

The FDA product code for Endoform Plastics and Reconstructive Matrix is FTM.

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: FTM)

K262406EluPro Antibiotic-Eluting BioEnvelopeBoston Scientific K250598Endoform Reconstructive Template - PLGAAroa Biosurgery , Ltd.K243595OviTex PRS (Long-Term Resorbable)TELA Bio, Inc.K233991CanGaroo RM Antibacterial EnvelopeElutia, Inc.K241126OviTex PRSTELA Bio, Inc.K223052Peri-Guard and Supple Peri-GuardSynovis Life Technologies, Inc.

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