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Medical Devices / Submissions and Approvals

Gel-E Recieves Expanded Clearance for Flowable Hemostat

July 5, 2018

The FDA granted expanded 510(k) clearance for OTC use of the Gel-E-Flex, a flowable hemostat used to stop bleeding.

The expanded clearance allows the product to be used by patients themselves and enables the product’s inclusion in Gel-E’s product, the 21st Century First Aid Kit, currently in development.

The device uses technology that enhances the characteristics of natural polysaccharides and it can be infused with other products to enhance hemostatic performance.

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