FCEClass I

Enema Kit

Gastroenterology, Urology · 21 CFR 876.5210

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.

MDR events69All time

Recalls0All time

Registered firms73Currently listed

510(k) clearances30All time