Arch Therapeutics Gets 510(k) Clearance for Topical Gel
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.