Cohera Medical, Inc.

Cohera Medical, Inc. specializes in surgical internal adhesives made from synthetic polymers. These products are formulated to seal internal tissues during surgical procedures, helping achieve hemostasis and tissue adhesion without relying on sutures or staples. Their primary focus is on medical adhesives designed for internal use in operating rooms.

Cohera Medical, Inc. is based in the United States. The company’s devices fall under the FDA’s regulatory oversight, specifically classified as Class III. This classification requires Premarket Approval (PMA) due to the higher risk associated with surgical adhesives, ensuring their safety and effectiveness before market authorization. Additionally, their devices are listed in the FDA’s Unique Device Identifier (UDI) database for traceability and compliance tracking.

Cohera Medical’s devices are included in the FDA’s Premarket Approval (PMA) registry and the FDA’s Unique Device Identifier (UDI) database. These registries ensure transparency in device authorization, manufacturing details, and compliance with U.S. regulatory requirements. The UDI system also supports post-market surveillance and tracking of surgical adhesives in clinical use.

The FDA categorizes Cohera Medical’s surgical adhesives as Class III because they are intended for internal use in surgical procedures where failure could cause serious harm or death. Class III devices require scientific evidence of safety and effectiveness through a Premarket Approval (PMA) process, as opposed to less stringent classifications like Class I or II. This classification reflects the higher risk associated with internal tissue adhesion and hemostasis in critical surgical settings.