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# Synedgen 510(k) Cleared for Wound Hydrogel
- URL: https://www.fdaweb.com/synedgen-510-k-cleared-for-wound-hydrogel/
- Published: 2018-05-23T12:00:00.000Z
- Updated: 2026-09-15T00:07:09.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5141523

FDA has cleared a Synedgen 510(k) for its Catasyn Advanced Technology Wound Hydrogel for use under the direction of a health care professional and over-the-counter (OTC) use. When administered by a healthcare professional, Catasyn can be used for dressing and managing partial to full thickness dermal ulcers including pressure sores, venous stasis ulcers, arterial ulcers and diabetic ulcers, surgical wounds including post-operative incisions and donor sites and superficial and partial thickness (second degree) burns. In its OTC indication, Catasyn can be used for dressing and managing minor burns, minor cuts, minor lacerations, minor abrasions, and minor irritations of the skin.