The Water Lily

FDA 510(k) K094022 · Clearwater Products, LLC

Substantially Equivalent

510(k) numberK094022

Submission

Device name
The Water Lily
Applicant
Clearwater Products, LLC
Crofton, MD, US
Received
December 30, 2009
Decision date
June 11, 2010
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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K051344Colonic and Enema NozzleKPL · Special Ultimate Concepts, Inc.08/18/2005SE
K050992Conmed Irrigation NozzleKPL · Traditional Conmedcorp07/14/2005SE
K050112Pro Fit Disposable Rectal Speculum, Models 8116 and 8117KPL · Traditional Prime Pacific Health Innovations Corporation03/15/2005SE
K033149Ultimate Professional Continuous Flow Colonic SystemKPL · Traditional Ultimate Concepts, Inc.03/23/2004SE

Questions and answers

When was The Water Lily cleared by the FDA?

The Water Lily (K094022) received a 510(k) decision of Substantially Equivalent on June 11, 2010, 163 days after the submission was received.

What is the product code of K094022?

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