Hessler Colon Therapy Device

FDA 510(k) K800565 · Hessler Mfg. Co.

Substantially Equivalent

510(k) numberK800565

Submission

Device name
Hessler Colon Therapy Device
Applicant
Hessler Mfg. Co.
Mchenry, IL, US
Received
March 13, 1980
Decision date
June 26, 1980
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

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K201861Bio Fluff SystemKPL · Traditional Gnali Bocia S.R.L.03/02/2022SE
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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 Hessler Colon Therapy Device cleared by the FDA?

Hessler Colon Therapy Device (K800565) received a 510(k) decision of Substantially Equivalent on June 26, 1980, 105 days after the submission was received.

What is the product code of K800565?

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