FDA Product Code FDS: Gastroscope And Accessories, Flexible/rigid

Gastroscopy is the gold standard for the diagnosis and treatment of upper gastrointestinal disorders. FDA product code FDS covers flexible and rigid gastroscopes and their accessories.

These endoscopic instruments allow clinicians to directly visualize the esophagus, stomach, and proximal duodenum for the diagnosis of ulcers, tumors, and inflammatory conditions, and for therapeutic procedures including biopsy, polypectomy, and hemostasis.

FDS devices are Class II medical devices, regulated under 21 CFR 876.1500 and reviewed by the FDA Gastroenterology & Urology panel.

Leading manufacturers include Fujifilm Corporation, Pentax of America, Inc. and EvoEndo, Inc..