FDA Product Code FER: Anoscope And Accessories
To Examine And Perform Procedures Within The Anus And Rectum.
Leading manufacturers include Applied Medical Resources, Gastro Concepts, LLC and Haemoband Surgical, Ltd..
FDA 510(k) Cleared Anoscope And Accessories Devices (Product Code FER)
About Product Code FER - Regulatory Context
510(k) Submission Activity
27 total 510(k) submissions under product code FER since 1977, with 27 receiving FDA clearance (average review time: 118 days).
Submission volume has increased in recent years - 2 submissions in the last 24 months compared to 1 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under FER have taken an average of 159 days to reach a decision - up from 114 days historically. Manufacturers should account for longer review timelines in current project planning.
FER devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →