ASPIDE MEDICAL

Aspide Medical specializes in extra-gynaecological surgical mesh made from synthetic polymers that are not bioabsorbable. These devices are primarily designed for procedures like pelvic organ prolapse repair and stress urinary incontinence treatment. The focus is on durable, long-term support for pelvic floor reconstruction.

Aspide Medical is headquartered in the United States. Since its devices fall under FDA jurisdiction, they are subject to U.S. regulatory requirements, including classification as Class II. This classification means the devices undergo specific premarket notifications (510(k)) and unique device identification (UDI) registration to ensure compliance with safety and performance standards.

Aspide Medical’s devices are listed in the FDA’s 510(k) and UDI registries. The 510(k) registry documents premarket submissions for Class II devices, demonstrating that each product meets FDA requirements for safety and effectiveness through a comparison to a legally marketed predicate. The UDI registry ensures traceability and transparency in the supply chain, allowing for better tracking of devices post-market.

Aspide Medical’s devices are classified as Class II under FDA regulations, which means they pose moderate risk and require special controls beyond general controls to ensure safety and performance. This classification requires manufacturers to submit a 510(k) premarket notification, proving the device is substantially equivalent to a legally marketed predicate. For clinicians, this classification indicates that the devices have undergone additional scrutiny to validate their design and intended use.