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510(k) Data Aggregation
K Number
K212521Device Name
Field Shield Wound Dressing
Manufacturer
Kericure Inc.
Date Cleared
2024-07-18
(1073 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
Kericure Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Rx
Management of partial and full thickness wounds including stage I - IV pressure ulcers, ulcers caused by mixed vascular etiologies, Diabetic skin ulcers, 1st and 2nd degree burns, post-surgical incisions, graft sites, lacerations, skin tears, cuts and abrasions.
OTC
Management of minor wounds including minor cuts, abrasions, lacerations and burns.
Device Description
The Field Shield Wound Dressing is a spray on hydrogel wound dressing that hydrates, seals and protects dermal injuries to create and maintain a moist wound environment. A moist wound environment is known to be conducive to the wound healing process. It is a hydrophilic system containing a polyacrylate polymer matrix with silver hydrosol and lidocaine. The dressing donates moisture to a wound and maintains a moist environment. When applied to the liquid device donates moisture to the wound then sets into a thin, pliable, transparent film barrier over the surface of the wound. The film is capable of setting over intact and compromised skin surfaces. The device is intended for use for up to 30 days. with reapplication recommended every 24 to 72 hours. The device contains silver hydrosol that may inhibit the growth of microorganisms such as Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli, antibiotic resistant strains of MRSA and VRE, as well as fungi such as Candida albicans and Candida auris within the dressing. Additionally, the dressing contains lidocaine as a topical anesthetic. Clinical evaluation showed that the Lidocaine can reduce pain within 30 minutes after application; long-term pain reduction has not been evaluated. Field Shield® Wound Dressing is intended for both Prescription and over the counter (OTC) indications for use.
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K Number
K131384Device Name
KERICURE ADVANCED LIQUID BANDAGE, NATURAL SEAL LIQUID BANDAGE, LIQUID BANDAGE
Manufacturer
KERICURE INC.
Date Cleared
2014-08-07
(450 days)
Product Code
KMF
Regulation Number
880.5090Why did this record match?
Applicant Name (Manufacturer) :
KERICURE INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
KeriCure™ Liquid Bandage and KeriCure Natural Seal™ Liquid Bandage: To help cover and protect the skin from infection in minor cuts, scrapes, burns, irritations and abrasions.
KeriCure™ Advanced Liquid Bandage: To cover and protect the skin from infection in minor cuts, scrapes, burns, irritations and abrasions, as well as closed surgical incisions and excisions.
Device Description
The KeriCure™ Liquid Bandage family of products is comprised of a protective, elastic polymer film (proprietary polyacrylate polymer). As applied to the skin, the liquid bandage is slightly more viscous than water and sets within minutes to form a clear, breathable and completely transparent film. The Liquid Bandage is capable of adhering to both intact and compromised body tissue. The device is available with either a dropper or spray applicator.
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