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. and Olympus Medical Systems Corp..
List of Biopsy Needle devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Biopsy Needle devices (product code FCG). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Gastroenterology & Urology FDA review panel. Browse all Gastroenterology & Urology devices →