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FDA 510(k)

KeraStat(R) Gel

K-Number: K162759 · 2017-06-02

ApplicantKeranetics, LLC
Decision Date2017-06-02
Product CodeKGN
DecisionSubstantially Equivalent

Device Summary

KeraStat(R) Gel is a medical device manufactured by Keranetics, LLC. It received FDA 510(k) clearance on 2017-06-02 under approval 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. It is manufactured by Keranetics, LLC. The 510(k) number is K162759.

When was KeraStat(R) Gel approved by the FDA?

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

What company makes KeraStat(R) Gel?

KeraStat(R) Gel is manufactured by Keranetics, LLC.

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

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

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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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