Hydro-Clenz Unit

FDA 510(k) K863539 · Atlantic Health Group

Substantially Equivalent

510(k) numberK863539

Submission

Device name
Hydro-Clenz Unit
Applicant
Atlantic Health Group
Norcross, GA, US
Received
September 11, 1986
Decision date
October 16, 1986
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

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

Other 510(k)s with product code KPL

510(k)DeviceApplicantDecision
K201861Bio Fluff SystemKPL · Traditional Gnali Bocia S.R.L.03/02/2022SE
K180800Colonic Plus Regular, Small, and Straight Shape HydrokitKPL · Traditional Colonic Plus06/01/2018SESK
K152834Colonplus Colonkit small, Colonplus Colonkit large, Colonplus Colonkit with Stop Collar…KPL · Traditional Colonplus Equipments & Speculums, S.L.08/10/2016SE
K150381Aqua CleanseKPL · Traditional Quality Medical Supply, Inc.09/11/2015SE
K131852HC-1 and HC-1 ClassicKPL · Traditional Transcendencias Comerciales SL Transcom04/17/2014SE
K094022The Water LilyKPL · Traditional Clearwater Products, LLC06/11/2010SE
K071057Colonic & Enema NozzleKPL · Traditional Tiller Mind Body, Inc.10/05/2007SE
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

Questions and answers

When was Hydro-Clenz Unit cleared by the FDA?

Hydro-Clenz Unit (K863539) received a 510(k) decision of Substantially Equivalent on October 16, 1986, 35 days after the submission was received.

What is the product code of K863539?

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