DeviceClearance

Product code FAM— Gastroenterology, Urology

BRIDGE, SHORT DEFLECTING

Classification name
Sigmoidoscope And Accessories, Flexible/Rigid
Device class
Class 2
Regulation
21 CFR 876.1500
Advisory panel
Gastroenterology, Urology
Total cleared
24
First cleared
Most recent

FDA classification definition

“to examine and perform procedures within the sigmoid (descending) colon”

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

Market context for product code FAM

FDA has cleared 24 devices under product code FAM between 1976 and 1997, filed by 11 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

Top applicants under product code FAM

Recent clearances under product code FAM

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