FDA 510(k)

SurgiPure XD Reconstructive Tissue Matrix

Номер K: K152206 · 2016-03-08

Дата решения2016-03-08

Код продуктаFTM

Консультативный комитетSU

РешениеSubstantially Equivalent

Описание устройства

SurgiPure XD Reconstructive Tissue Matrix is the device name listed in this FDA 510(k) record. The listed applicant is Tissue Regenix Group Plc. It received FDA 510(k) clearance on 2016-03-08 under 510(k) number K152206. 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 SurgiPure XD Reconstructive Tissue Matrix?

SurgiPure XD Reconstructive Tissue Matrix is a medical device that received FDA 510(k) clearance on 2016-03-08. The listed applicant is Tissue Regenix Group Plc. The 510(k) number is K152206.

When did SurgiPure XD Reconstructive Tissue Matrix receive FDA 510(k) clearance?

SurgiPure XD Reconstructive Tissue Matrix received FDA 510(k) clearance on 2016-03-08, under 510(k) number K152206.

Who is the listed applicant for SurgiPure XD Reconstructive Tissue Matrix?

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

What is the FDA product code for SurgiPure XD Reconstructive Tissue Matrix?

The FDA product code for SurgiPure XD Reconstructive Tissue 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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