FDA Product Code FCG: Biopsy Needle

Under FDA product code FCG, biopsy needles for gastrointestinal use are cleared for percutaneous or endoscopic tissue sampling.

These needles are used to obtain tissue cores from the liver, pancreas, kidney, and other abdominal organs under ultrasound or CT guidance, or through an endoscopic ultrasound catheter. Core biopsy provides histological samples for the diagnosis of malignancy and liver disease.

FCG devices are Class II medical devices, regulated under 21 CFR 876.1075 and reviewed by the FDA Gastroenterology & Urology panel.

Leading manufacturers include Cook Ireland, Ltd., Olympus Medical Systems Corp. and Wilson-Cook Medical, Inc..