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FDA 510(k)

INTEGRA MESHED BILAYER WOUND MATRIX

K-Number: K081635 · 2008-12-04

ApplicantIntegra Lifesciences Corp.
Decision Date2008-12-04
Product CodeKGN
DecisionSubstantially Equivalent

Device Summary

INTEGRA MESHED BILAYER WOUND MATRIX is the device name listed in this FDA 510(k) record. The listed applicant is Integra Lifesciences Corp.. It received FDA 510(k) clearance on 2008-12-04 under 510(k) number K081635. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INTEGRA MESHED BILAYER WOUND MATRIX?

INTEGRA MESHED BILAYER WOUND MATRIX is a medical device that received FDA 510(k) clearance on 2008-12-04. The listed applicant is Integra Lifesciences Corp.. The 510(k) number is K081635.

When did INTEGRA MESHED BILAYER WOUND MATRIX receive FDA 510(k) clearance?

INTEGRA MESHED BILAYER WOUND MATRIX received FDA 510(k) clearance on 2008-12-04, under 510(k) number K081635.

Who is the listed applicant for INTEGRA MESHED BILAYER WOUND MATRIX?

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

What is the FDA product code for INTEGRA MESHED BILAYER WOUND MATRIX?

The FDA product code for INTEGRA MESHED BILAYER WOUND MATRIX is KGN.

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Related Devices (Code: KGN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260652ColActive PlusCovalon Technologies, Ltd.K260711Accelagen Plus Surgical Matrix, 1cc (CG-01AP);Accelagen Plus Surgical Matrix, 3cc (CG-03AP);Accelagen Plus Surgical Matrix, 5cc (CG-05AP);Accelagen Plus Surgical Strip, 125x25x2mm (CG-125X25AP);Accelagen Plus Surgical Strip, 250x25x2mm (CG-250X25AP)Berkeley Advanced BiomaterialsK260596Collagen Wound PowderVentris MedicalK260669Endoform Dermal TemplateAroa Biosurgery , Ltd.K253521ECMT-100 WMDEcm Therapeutics, Inc.K253204CatalyzeBioTissue Holdings, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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