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..
FDA 510(k) Cleared Gastroscope And Accessories, Flexible/rigid Devices (Product Code FDS)
About Product Code FDS - Regulatory Context
510(k) Submission Activity
75 total 510(k) submissions under product code FDS since 1983, with 75 receiving FDA clearance (average review time: 145 days).
Submission volume has increased in recent years - 15 submissions in the last 24 months compared to 4 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under FDS have taken an average of 181 days to reach a decision - up from 136 days historically. Manufacturers should account for longer review timelines in current project planning.
FDS devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →