Gel-E wins FDA OTC nod for gel-e Flex flowable hemostat

Early stage wound care company Gel-e said today it won FDA 510(k) clearance for its gel-e Flex as an over-the-counter flowable hemostat.
The College Park, Md.-based company said the clearance expands the labeling for the local management of lacerations and minor bleeding, and said the products were specifically designed to be usable by both trained professionals and patients.
“This clearance is the next step in expanding our OTC product line, and will be a key component of gel-e’s 21st Century First Aid Kit. We are continuing to develop a tool kit that will provide the best possible options for all manner of chronic and acute wounds. The versatility of these flowable and bandage formats represents an important progression towards our next-generation kit and eventually to products that can be used in surgery,” chief scientific officer Dr. Matthew Dowling said in a press release.
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Source: Mass Device - June 29, 2018 Category: Medical Devices Authors: Fink Densford Tags: 510(k) Food & Drug Administration (FDA) Regulatory/Compliance Wound Care gel-e Source Type: news