FDA 510(k)

DuraGen Secure Dural Regeneration Matrix

N.º K: K163456 · 2017-01-06

SolicitanteIntegra LifeSciences Corporation

Fecha de decisión2017-01-06

Código de productoGXQ

Comité asesorNE

DecisiónSubstantially Equivalent

Resumen del dispositivo

DuraGen Secure Dural Regeneration Matrix is the device name listed in this FDA 510(k) record. The listed applicant is Integra LifeSciences Corporation. It received FDA 510(k) clearance on 2017-01-06 under 510(k) number K163456. The device is classified under product code GXQ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the DuraGen Secure Dural Regeneration Matrix?

DuraGen Secure Dural Regeneration Matrix is a medical device that received FDA 510(k) clearance on 2017-01-06. The listed applicant is Integra LifeSciences Corporation. The 510(k) number is K163456.

When did DuraGen Secure Dural Regeneration Matrix receive FDA 510(k) clearance?

DuraGen Secure Dural Regeneration Matrix received FDA 510(k) clearance on 2017-01-06, under 510(k) number K163456.

Who is the listed applicant for DuraGen Secure Dural Regeneration Matrix?

The FDA 510(k) record lists Integra LifeSciences Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DuraGen Secure Dural Regeneration Matrix?

The FDA product code for DuraGen Secure Dural Regeneration Matrix is GXQ.

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Dispositivos relacionados (Código: GXQ)

K251191Collagen Dura Regeneration Membrane - RepairCollagen Matrix, Inc.K250420Helios Dura Regeneration MatrixHelios Biomedical, Inc.K223445ArtiFasciaNurami Medical , Ltd.K212943SyntheCel Dura RepairSynthes (USA) Products, LLC K183513XenoSure Dura Biologic PatchLeMaitre Vascular, Inc.K172603Cerafix Dura SubstituteAcera Surgical, Inc.

Fuente oficial

Ver en la base de datos de la FDA →

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