FCE

Enema Kit

Product code

FCE

Device name

Enema Kit

Device class

Class 1

21 CFR

21 CFR 876.5210

Medical specialty

Gastroenterology, Urology

Marketing pathway

510(K) Exempt

Flag

GMP exempt

510(k) clearances (last 3 years)

30

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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).