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FDA 510(k)

INTEGRA Wound Matrix (Macro-Channels)

K-Number: K210128 · 2021-10-08

ApplicantIntegra LifeSciences Corporation
Decision Date2021-10-08
Product CodeKGN
DecisionSubstantially Equivalent

Device Summary

INTEGRA Wound Matrix (Macro-Channels) 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 2021-10-08 under 510(k) number K210128. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INTEGRA Wound Matrix (Macro-Channels)?

INTEGRA Wound Matrix (Macro-Channels) is a medical device that received FDA 510(k) clearance on 2021-10-08. The listed applicant is Integra LifeSciences Corporation. The 510(k) number is K210128.

When did INTEGRA Wound Matrix (Macro-Channels) receive FDA 510(k) clearance?

INTEGRA Wound Matrix (Macro-Channels) received FDA 510(k) clearance on 2021-10-08, under 510(k) number K210128.

Who is the listed applicant for INTEGRA Wound Matrix (Macro-Channels)?

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 INTEGRA Wound Matrix (Macro-Channels)?

The FDA product code for INTEGRA Wound Matrix (Macro-Channels) is KGN.

Related Clinical Trials

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.

NCT06857708The Management of Necrotizing Soft Tissue Infection Wounds With Cytal® Wound Matrix and MicroMatrix®RECRUITINGNCT06453187A Modified Platform Trial of Multiple CAMPs for the Management of Diabetic Foot Ulcers and Venous Leg UlcersENROLLING_BY_INVITATION

Other records listing Integra LifeSciences Corporation as applicant

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.

PMA P850010Agent, absorbable hemostatic, collagen basedPMA P840062MATERIAL, DRESSING, SURGICAL, POLYLACTIC ACIDPMA P810006Agent, absorbable hemostatic, collagen basedPMA P080013Sealant, duralPMA P040034Sealant, duralPMA P900033Dressing, wound and burn, interactive

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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.

K260596Collagen Wound PowderVentris MedicalK260669Endoform Dermal TemplateAroa Biosurgery , Ltd.K253521ECMT-100 WMDEcm Therapeutics, Inc.K253204CatalyzeBioTissue Holdings, Inc.K254034Roosin Collagen PowderRoosin Medical Co., Ltd.K253974Roosin Collagen DressingRoosin Medical Co., Ltd.

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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