DeviceClearance

Product code FCD— Gastroenterology, Urology

PRO-FLO SYSTEM WITH INFRA-RED REMOTE CONTROL

Classification name
Barium Enema Kit
Device class
Class 1
Regulation
21 CFR 876.5210
Advisory panel
Gastroenterology, Urology
Total cleared
2
First cleared
Most recent

FDA classification definition

“This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.”

— U.S. Food and Drug Administration, device classification record for product code FCD under 21 CFR 876.5210, via openFDA

Market context for product code FCD

FDA has cleared 2 devices under product code FCD between 1987 and 1993, filed by 2 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

Clearances per year

Top applicants under product code FCD

Recent clearances under product code FCD

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