Clearance for New Wound Hydrogel

Synedgen (Claremont, CA) announced that its Catasyn Advanced Technology Wound Hydrogel received 510(k) clearance from the Food and Drug Administration. The product can be marketed as both under the direction of a health care professional or over-the-counter application. It is the third marketed product in the company’s wound care portfolio, which includes SynePure Wound Cleanser and Synoplex.

When administered by a clinician, the hydrogel can be used for the management of partial- and full-thickness wounds such as pressure, venous stasis, arterial, and diabetic ulcers; surgical wounds, including postoperative incisions and donor site wounds; and superficial and partial-thickness burns. The over-the-counter indiciation is for minor burns, cuts, lacerations, abrasions, and skin irritations.

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