Z-Medica, LLC announces that QuikClot® Control+™ has been cleared for use by the U.S. Food and Drug Administration (FDA) under the de novo classification process and is designated as a Class II medical device.
For those of you who are familiar with TraumaPads, this is the next generation of the product where the active ingredient is bonded to the woven sponge, resulting in easier removal from the abdominal cavity as well as zero chance of kaolin embolization. This marks the first product of its kind with internal indications.
It was data from Cooper University Hospital that the FDA used to make their final determination to grant approval for this product.
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