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510(k) Data Aggregation
K Number
K173544Device Name
Phoenix Wound Matrix
Manufacturer
Nanofiber Solutions, Inc.
Date Cleared
2018-03-02
(106 days)
Product Code
QSZ, FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
Nanofiber Solutions, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Phoenix Wound Matrix is intended for use in the management of wounds. Wound types include: Partial and fullthickness wounds, pressure ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds (donor sites/grafts, post-Moh's surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second degree burns, skin tears) and draining wounds.
Device Description
The Phoenix Wound Matrix is a sterile, single use device intended for the management of wounds. The Phoenix Wound Matrix is a conformable, non-woven, fibrous, three-dimensional matrix. The Phoenix Wound Matrix is made from two types of polymer fibers: Poly(lactide-co-caprolactone) and Polyglycolic acid, which are bioabsorbed after degrading via hydrolysis.
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