gel-e Inc., announces the 510(k) clearance of gel-e FLEX by the U.S. Food and Drug Administration (FDA) for the over-the-counter (OTC) use of its first flowable hemostat.
This new clearance expands the Company’s label that now includes the use of gels and bandages in the local management of bleeding, such as lacerations and minor bleeding. These products are specifically designed to create rapid hemostasis through easy-to-use applications for professional healthcare providers, parents, coaches, adult caregivers and even patients themselves. gel-e FLEX also complements the Company’s already FDA cleared vascular closure device, Vascular gel-e®, as it can be worn home by patients to manage any residual bleeding from an out-patient diagnostic or interventional procedure, see http://www.gel-e.co/products.html.