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FDA 510(k)

Flowable Wound Matrix

K-Number: K160136 · 2016-09-28

ApplicantCook Biotech Incorporated
Decision Date2016-09-28
Product CodeKGN
DecisionSubstantially Equivalent

Device Summary

Flowable Wound Matrix is a medical device manufactured by Cook Biotech Incorporated. It received FDA 510(k) clearance on 2016-09-28 under approval number K160136. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Flowable Wound Matrix?

Flowable Wound Matrix is a medical device that received FDA 510(k) clearance on 2016-09-28. It is manufactured by Cook Biotech Incorporated. The 510(k) number is K160136.

When was Flowable Wound Matrix approved by the FDA?

Flowable Wound Matrix received FDA 510(k) clearance on 2016-09-28, under approval number K160136.

What company makes Flowable Wound Matrix?

Flowable Wound Matrix is manufactured by Cook Biotech Incorporated.

What is the FDA product code for Flowable Wound Matrix?

The FDA product code for Flowable Wound Matrix is KGN.

Related Clinical Trials

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Other Devices by Cook Biotech Incorporated

K162741AxoGuard Nerve Connector K161221Biodesign Sling, Biodesign Plastic Surgery Matrix, Biodesign Anal Fistula Plug K161000Biodesign Otologic Repair Graft K160869Biodesign Tissue Graft, Biodesign Dural Graft, Biodesign Peyronie's Repair Graft K162934Biodesign Parastomal Hernia Repair Graft K170016Biodesign Fistula Plug

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Related Devices (Code: KGN)

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 K172399MicroMatrixAcell, 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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