Cresilon, Inc.

Cresilon, Inc. specializes in non-antimicrobial wound hydrogel dressings. These products are primarily designed for hemostasis (stopping bleeding) and wound care, including gel-based solutions for trauma and surgical applications. The company’s portfolio includes products like TRAUMAGEL® and Cresilon Hemostatic Gel, which are intended to aid in controlling bleeding and promoting wound healing.

Cresilon, Inc. is based in the United States. Its devices are listed in the FDA’s 510(k) premarket notification registry and the FDA’s Unique Device Identification (UDI) system. These registries track devices that have undergone the necessary regulatory pathways to demonstrate safety and effectiveness for their intended use.

Cresilon, Inc.’s wound hydrogel dressings fall under the U.S. FDA’s Class II (U) device classification. This classification applies to products that generally pose moderate risk and require special controls—such as performance standards or post-market surveillance—to ensure their safety and effectiveness. The company’s products are subject to these controls as part of their regulatory compliance.

Cresilon, Inc.’s products are specifically designed as non-antimicrobial wound hydrogel dressings, which means they do not contain agents to fight bacteria. Instead, they focus on hemostasis and wound care through gel-based formulations like TRAUMAGEL® and Cresilon Hemostatic Gel. This distinction is important for applications where antimicrobial properties are not required, such as certain trauma or surgical scenarios.