(61 days)
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.
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.
This document is a 510(k) summary for the Stasilon FR™ device, a hemostatic wound dressing. It declares substantial equivalence to previously marketed predicate devices but does not contain information about specific acceptance criteria or an associated study proving the device meets those criteria.
Therefore, I cannot provide the requested information based on the provided text. The document focuses on regulatory classification, indications for use, and a general comparison to predicate devices, but lacks detailed performance data, study design, or ground truth establishment.
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