DeviceClearance

Product code FER— Gastroenterology, Urology

ANGIOSCOPE W/INTEGRATED IRRIGATING CHANNEL

Classification name
Anoscope And Accessories
Device class
Class 2
Regulation
21 CFR 876.1500
Advisory panel
Gastroenterology, Urology
Total cleared
27
First cleared
Most recent

FDA classification definition

“To examine and perform procedures within the anus and rectum.”

— U.S. Food and Drug Administration, device classification record for product code FER under 21 CFR 876.1500, via openFDA

Market context for product code FER

FDA has cleared 27 devices under product code FER between 1977 and 2025, filed by 19 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

last 15 years

Top applicants under product code FER

Recent clearances under product code FER

Data sourced from openFDA. This site is unofficial and independent of the FDA.