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510(k) Data Aggregation
K Number
K072890Device Name
STASILON FR
Manufacturer
ENTEGRION, INC.
Date Cleared
2007-12-10
(61 days)
Product Code
QSY, FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
ENTEGRION, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Stasilon FR™ is a single-use hemostatic wound dressing applied externally with mechanical compression to temporarily control bleeding in lacerations, punctures, abrasions and incisions.
Stasilon FR™ is indicated to temporarily control bleeding in minor cuts, lacerations, punctures, abrasions and incisions.
Device Description
Stasilon™ is a textile technology that is manufactured from two component yarns: continuous filament fiber glass yarn and bamboo yarn. It is woven to a specific width and cut to length. The cut edges are sealed with a small amount of high melt temperature pure paraffin wax. The device is typically finished as a flat, four-inch square (4"x4"), single-layer pad that is individually packaged, sealed and Gamma sterilized at 25 kGy (SAL 10°) and sold under the trade name Stasilon FR™.
The component yarn materials and proprietary weave provide wound protection, reduce blood loss after contact with the wound, and help retain clot integrity during removal. The device shows superior performance when compared to the gauze control in animal models.
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