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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 the device name listed in this FDA 510(k) record. The listed applicant is Cook Biotech Incorporated. It received FDA 510(k) clearance on 2016-09-28 under 510(k) 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. The listed applicant is Cook Biotech Incorporated. The 510(k) number is K160136.

When did Flowable Wound Matrix receive FDA 510(k) clearance?

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

Who is the listed applicant for Flowable Wound Matrix?

The FDA 510(k) record lists Cook Biotech Incorporated as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Flowable Wound Matrix?

The FDA product code for Flowable 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.

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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