FDA 510(k)

KeraStat(R) Gel

K-Number: K162759 · 2017-06-02

Decision Date2017-06-02

Product CodeKGN

DecisionSubstantially Equivalent

Device Summary

KeraStat(R) Gel is the device name listed in this FDA 510(k) record. The listed applicant is Keranetics, LLC. It received FDA 510(k) clearance on 2017-06-02 under 510(k) number K162759. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KeraStat(R) Gel?

KeraStat(R) Gel is a medical device that received FDA 510(k) clearance on 2017-06-02. The listed applicant is Keranetics, LLC. The 510(k) number is K162759.

When did KeraStat(R) Gel receive FDA 510(k) clearance?

KeraStat(R) Gel received FDA 510(k) clearance on 2017-06-02, under 510(k) number K162759.

Who is the listed applicant for KeraStat(R) Gel?

The FDA 510(k) record lists Keranetics, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KeraStat(R) Gel?

The FDA product code for KeraStat(R) Gel is KGN.

Other records listing Keranetics, LLC 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.

K192386KeraStat Cream

Related Devices (Code: KGN)

K260596Collagen Wound PowderVentris Medical K260669Endoform 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

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