ABIGO Medical AB

Abigo Medical AB specializes in wound care dressings and ear canal irrigation devices. Their portfolio includes products like ribbon gauze, foam borders, superabsorbent materials, and OTOVENT, which is designed for cleaning and irrigating the ear canal. These devices are formulated to manage exudate, promote wound healing, and reduce bacterial adhesion in both acute and chronic wounds.

Abigo Medical AB is based in the United States. Their devices are classified as Class II under FDA regulations and are registered in the FDA’s 510(k) database, meaning they undergo the 510(k) premarket notification process to demonstrate substantial equivalence to a legally marketed predicate device.

Abigo Medical AB’s devices are classified as Class II by the FDA. This classification is typically assigned to devices that pose moderate risk and require special controls to ensure their safety and effectiveness. The 510(k) pathway is used for these devices to demonstrate that they are substantially equivalent to a previously cleared device, ensuring they meet regulatory standards without requiring the more stringent premarket approval process.

Yes, Abigo Medical AB’s devices are listed in the FDA’s 510(k) database. This registry tracks devices that have undergone the 510(k) premarket notification process, confirming they meet regulatory requirements for safety and performance before being marketed in the United States.