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510(k) Data Aggregation
K Number
K172593Device Name
XCelliStem Wound Powder
Manufacturer
Date Cleared
2018-03-16
(199 days)
Product Code
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
StemSys
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The XCelliStem Wound Powder is intended for the management of wounds including: partial and full-thickness wounds, pressure ulcers, diabetic ulcers, venous ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second-degree burns, and skin tears), and draining wounds. The device is intended for one-time use.
Device Description
The XCelliStem Wound Powder is an extracellular matrix composed of porcine collagen for the management of wounds. It is white to off-white particulate that is to be used as a topical application. The product is provided sterile, for single use.
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