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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 a medical device manufactured by Integra LifeSciences Corporation. It received FDA 510(k) clearance on 2021-10-08 under approval 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. It is manufactured by Integra LifeSciences Corporation. The 510(k) number is K210128.

When was INTEGRA Wound Matrix (Macro-Channels) approved by the FDA?

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

What company makes INTEGRA Wound Matrix (Macro-Channels)?

INTEGRA Wound Matrix (Macro-Channels) is manufactured by Integra LifeSciences Corporation.

What is the FDA product code for INTEGRA Wound Matrix (Macro-Channels)?

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

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Related Devices (Code: KGN)

K160136Flowable Wound MatrixCook Biotech Incorporated K152600Collagen Dental Wound DressingsCollagen Matrix, Inc. K153754MicroMatrixAcell, Inc. K153690PriMatrix Dermal Repair ScaffoldTei Biosciences, Inc. K172010gel-e BandageGel-E, Inc. (Formerly Remedium Technologies, Inc.) K171842Geistlich Wound MatrixGeistlich Pharma AG

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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