DeviceClearance

Product code FCC— Gastroenterology, Urology

BRIMFIELD CANNULATED MAGNETIC RETRIEVER

Classification name
Endoscopic Magnetic Retriever
Device class
Class 2
Regulation
21 CFR 876.1500
Advisory panel
Gastroenterology, Urology
Total cleared
3
First cleared
Most recent

FDA classification definition

“to endoscopically retrieve magnetic foreign objects”

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

Market context for product code FCC

FDA has cleared 3 devices under product code FCC between 1980 and 1991, filed by 3 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 FCC

Recent clearances under product code FCC

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