Entegrion, Inc., a privately owned life sciences product development company specializing in technologies for hemorrhage control, resuscitation, and tissue repair, announced that it has received 510(k) market approval from the U. S. Food and Drug Administration (FDA) for its hemostatic medical textile technology. The first application of the technology is Stasilon FR – hemostatic wound dressings for first responders. This market includes EMS workers, police officers, emergency personnel and fire fighters. The Stasilon FR – hemostatic wound dressing was approved by the FDA for use by medical professionals under prescription and “over-the-counter” by consumers to control bleeding resulting from “minor cuts and abrasions” as well as “lacerations, punctures and incisions.” Pending acceptance of an amendment to the FDA approval, a second version of the technology will be implemented as Stasilon OR – hemostatic surgical pads.
Entegrion 510K available HERE
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