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FDA 510(k)

KeraStat Cream

K-Number: K192386 · 2020-07-16

ApplicantKeranetics
Decision Date2020-07-16
Product CodeKGN
DecisionSubstantially Equivalent

Device Summary

KeraStat Cream is a medical device manufactured by Keranetics. It received FDA 510(k) clearance on 2020-07-16 under approval number K192386. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KeraStat Cream?

KeraStat Cream is a medical device that received FDA 510(k) clearance on 2020-07-16. It is manufactured by Keranetics. The 510(k) number is K192386.

When was KeraStat Cream approved by the FDA?

KeraStat Cream received FDA 510(k) clearance on 2020-07-16, under approval number K192386.

What company makes KeraStat Cream?

KeraStat Cream is manufactured by Keranetics.

What is the FDA product code for KeraStat Cream?

The FDA product code for KeraStat Cream is KGN.

Related Clinical Trials

NCT06441266 M-PART in Head and Neck Cancer Patients Treated With KeraStat Cream for Acute Radiation Dermatitis ACTIVE_NOT_RECRUITING

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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