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510(k) Data Aggregation
K Number
K192386Device Name
KeraStat Cream
Manufacturer
Date Cleared
2020-07-16
(317 days)
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
KeraNetics
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
KeraStat® Cream is intended to maintain a moist wound environment. KeraStat® Cream is indicated for the management of a number of partial thickness skin wounds such as: partial thickness (first and second degree) burns, superficial injuries, cuts, and incisions/surgical wounds. Under the direction of a healthcare professional, KeraStat® Cream also may be used in the management of dry, light, and moderately exuding partial thickness wounds including: pressure (stage I-II) ulcers, venous stasis ulcers caused by mixed vascular etiologies, diabetic ulcers, radiation dermatitis, donor sites, and grafts.
KeraStat® Cream is not indicated for full thickness or third degree will be available by prescription.
Device Description
KeraStat® Cream is a non-sterile, non-implantable wound dressing intended to provide a moist environment in the management of a variety of partial thickness dermal wounds. KeraStat® Cream is provided in a screw top tube for multiple uses. Each tube contains 1 oz (29.6 mL) of KeraStat® Cream, which contains 5% keratin protein incorporated into a cream base.
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K Number
K162759Device Name
KeraStat(R) Gel
Manufacturer
Date Cleared
2017-06-02
(245 days)
Product Code
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
KeraNetics, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
KeraStat® Gel is intended to provide a moist environment and absorb excess wound exudate. KeraStat® Gel is indicated for management of a number of partial thickness skin wounds such as: partial thickness (first and second degree) burns, severe sunburns, superficial injuries, cuts, and incisions/surgical wounds. Under the direction of a healthcare practitioner. KeraStat® Gel also may be used in the management of dry, light, and moderately exuding partial thickness wounds including: pressure (stage I-II) ulcers, venous stasis ulcers caused by mixed vascular etiologies, diabetic ulcers, donor sites, and grafts.
KeraStat® Gel is not indicated for full thickness (third degree) burns. This device will be available by prescription.
Device Description
KeraStat® Gel is a sterile, non-implantable, water-based gelatinous (hydrogel) wound dressing intended to act as a protective covering in the management of a variety of partial thickness dermal wounds. KeraStat Gel is provided in a sterile, screw top tube for one-time use. Each tube contains 5 mL of KeraStat Gel, which contains 5% keratin protein rehydrated and polymerized in a water base, and is available by prescription from a healthcare professional.
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