510(k) K152834

Colonplus Colonkit small, Colonplus Colonkit large, Colonplus Colonkit with Stop Collar 6, Colonplus Colonkit with Stop Collar 10 by Colonplus Equipments & Speculums, S.L. — Product Code KPL

K152834 is an FDA 510(k) premarket notification submitted by Colonplus Equipments & Speculums, S.L. for the device "Colonplus Colonkit small, Colonplus Colonkit large, Colonplus Colonkit with Stop Collar 6, Colonplus Colonkit with Stop Collar 10". The FDA issued a decision of Substantially Equivalent on August 10, 2016. The device falls under product code KPL (Colonic Irrigation System), a Class II device regulated under 21 CFR 876.5220.