Ultimate Professional Continuous Flow Colonic System

FDA 510(k) K033149 · Ultimate Concepts, Inc.

Substantially Equivalent

510(k) numberK033149

Submission

Device name
Ultimate Professional Continuous Flow Colonic System
Applicant
Ultimate Concepts, Inc.
Irvine, CA, US
Received
September 30, 2003
Decision date
March 23, 2004
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
KPL – Colonic Irrigation System
Device class
Class II (moderate risk)
Regulation
21 CFR 876.5220
Specialty
Gastroenterology, Urology

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Questions and answers

When was Ultimate Professional Continuous Flow Colonic System cleared by the FDA?

Ultimate Professional Continuous Flow Colonic System (K033149) received a 510(k) decision of Substantially Equivalent on March 23, 2004, 175 days after the submission was received.

What is the product code of K033149?

The FDA product code is KPL – Colonic Irrigation System, a Class II (moderate risk) device regulated under 21 CFR 876.5220.