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., Finemedix Co., Ltd. and Olympus Medical Systems Corp..
FDA 510(k) Cleared Biopsy Needle Devices (Product Code FCG)
About Product Code FCG - Regulatory Context
510(k) Submission Activity
133 total 510(k) submissions under product code FCG since 1977, with 133 receiving FDA clearance (average review time: 115 days).
Submission volume has declined in recent years - 3 submissions in the last 24 months compared to 6 in the prior period.
FDA Review Time
FDA review times for FCG submissions have been consistent, averaging 99 days recently vs 116 days historically.
FCG devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →