Arch Therapeutics Gets 510(k) Clearance for Topical Gel

March 23, 2020

Arch Therapeutics has received the FDA’s 510(k) clearance for its AC5 topical gel, a topical dressing used for wound management.

The topical gel is designed for use on partial and full-thickness wounds, including pressure sores, leg ulcers, diabetic ulcers, and surgical wounds.

The gel is applied directly to a patient’s wound as a liquid and does not rely on heat, pressure or adhesion.

The company is developing several AC5 products and has filed its first application for a CE Mark certification in Europe.

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