FDA 510(k)

GORE BIO-A Tissue Reinforcement

Número K: K163217 · 2017-02-10

Data da decisão2017-02-10

Código do produtoOXF

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

GORE BIO-A Tissue Reinforcement is the device name listed in this FDA 510(k) record. The listed applicant is W. L. Gore & Associates, Inc.. It received FDA 510(k) clearance on 2017-02-10 under 510(k) number K163217. The device is classified under product code OXF. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the GORE BIO-A Tissue Reinforcement?

GORE BIO-A Tissue Reinforcement is a medical device that received FDA 510(k) clearance on 2017-02-10. The listed applicant is W. L. Gore & Associates, Inc.. The 510(k) number is K163217.

When did GORE BIO-A Tissue Reinforcement receive FDA 510(k) clearance?

GORE BIO-A Tissue Reinforcement received FDA 510(k) clearance on 2017-02-10, under 510(k) number K163217.

Who is the listed applicant for GORE BIO-A Tissue Reinforcement?

The FDA 510(k) record lists W. L. Gore & Associates, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GORE BIO-A Tissue Reinforcement?

The FDA product code for GORE BIO-A Tissue Reinforcement is OXF.

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Outros registros que listam W. L. Gore & Associates, Inc. como candidato(a)

K250410GORE® Tri-Lobe Balloon Catheter K240083GORE® PROPATEN® Vascular Graft K232312GORE® PROPATEN® Vascular Graft K233551GORE® ACUSEAL Vascular Graft K231505GORE® ACUSEAL Vascular Graft K222919GORE® ENFORM Biomaterial

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Dispositivos Relacionados (Código: OXF)

K251224Restrata Soft Tissue Reinforcement (STR)Acera Surgical, Inc.K2433023DMatrix DynaFlex (DynaFlex)Printbio, Inc.K2326023DMatrix Surgical MeshPrintbio, Inc.K222919GORE® ENFORM BiomaterialW. L. Gore and Associates, Inc.K173333GORE ENFORM BiomaterialW. L. Gore & Associates, Inc.K172545SERI ContourSofregen Medical, Inc.

Fonte oficial

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