Gastro Concepts, LLC

Gastro Concepts, LLC specializes in colonoscope distal anchoring cuffs. These devices, such as the Air Assist and Gastro Concepts Air Assist, are designed to enhance stability and control during colonoscopy procedures by securing the distal tip of the colonoscope. The focus is on improving procedural efficiency and patient safety in gastrointestinal examinations.

Gastro Concepts, LLC is based in the United States. The company’s headquarters and operations are located within the country, which aligns with its regulatory compliance and manufacturing standards.

Gastro Concepts, LLC’s devices are listed in the FDA’s 510(k) and Unique Device Identification (UDI) registries. These registries track medical devices that have undergone the FDA’s premarket notification process (510(k)) and are assigned a UDI for traceability and identification purposes.

Gastro Concepts, LLC’s devices, including colonoscope distal anchoring cuffs like the Air Assist, are classified as Class II medical devices by the FDA. This classification indicates moderate risk and requires specific controls to ensure safety and effectiveness, such as performance standards and post-market surveillance.