DeviceClearance

Product code FCE— Gastroenterology, Urology

ENEMA KIT

Classification name
Enema Kit
Device class
Class 1
Regulation
21 CFR 876.5210
Advisory panel
Gastroenterology, Urology
Total cleared
30
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 FCE under 21 CFR 876.5210, via openFDA

Market context for product code FCE

FDA has cleared 30 devices under product code FCE between 1976 and 1997, filed by 22 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 FCE

Adverse events under product code FCE

product code FCE
Other
2
Total
2

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code FCE

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