FDA 510(k) Applications for Medical Device Product Code "KPL"
(Colonic Irrigation System)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K000388 | CLEARWATER COLON HYDROTHERAPY, INC. | CLEARWATER COLON HYDROTHERAPY (DISPOSABLE SPECULUM SPO1 LARGE & SP02 SMALL) | 08/08/2000 |
| K942867 | CLEARWATER COLON HYDROTHERAPY, INC. | CLEARWATER COLON HYDROTHERAPY MODEL PPC-101 | 06/26/1996 |
| K094022 | CLEARWATER PRODUCTS, LLC | THE WATER LILY | 06/11/2010 |
| K972455 | COLON THERAPEUTICS | JIMMY JOHN III RECTAL NOZZEL, MODEL CIT | 09/09/1997 |
| K973256 | COLON THERAPEUTICS | JIMMY JOHN III RECTAL NOZZLE | 09/29/1997 |
| K180800 | Colonic Plus | Colonic Plus Regular, Small, and Straight Shape Hydrokit | 06/01/2018 |
| K152834 | COLONPLUS EQUIPMENTS & SPECULUMS, S.L. | Colonplus Colonkit small, Colonplus Colonkit large, Colonplus Colonkit with Stop Collar 6, Colonplus Colonkit with Stop Collar 10 | 08/10/2016 |
| K050992 | CONMED CORP. | CONMED IRRIGATION NOZZLE | 07/14/2005 |
| K980868 | GENTLE COLONICS, INC. | GC IRRIGATOR | 08/06/1998 |
| K002102 | GENTLE COLONICS, INC. | GENTLE COLONICS IRRIGATION SYSTEM | 02/06/2002 |
| K201861 | Gnali Bocia S.R.L. | Bio Fluff System | 03/02/2022 |
| K003720 | LIFESTREAM PURFICATION SYSTEMS, LLC. | ANGEL OF WATER COLON HYDROTHERAPY SYSTEM | 06/27/2002 |
| K000031 | PRIME PACIFIC HEALTH INNOVATIONS CORPORATION | AQUANET, MODEL EC 2000 | 09/10/2001 |
| K050112 | PRIME PACIFIC HEALTH INNOVATIONS CORPORATION | PRO FIT DISPOSABLE RECTAL SPECULUM, MODELS 8116 AND 8117 | 03/15/2005 |
| K150381 | QUALITY MEDICAL SUPPLY, INC | AQUA CLEANSE | 09/11/2015 |
| K970482 | SRS INTL. | TRANSCOM COLON HYDROTHERAPY MODEL HC-2000 | 10/31/1997 |
| K071057 | TILLER MIND BODY, INC. | COLONIC & ENEMA NOZZLE | 10/05/2007 |
| K962259 | TILLER MIND BODY, INC. | LIBBE RECTAL TUBE (FORMERLY A YANKAUER SUCTION TUBE) | 08/29/1996 |
| K131852 | TRANSCENDENCIAS COMERCIALES SL TRANSCOM | HC-1 AND HC-1 CLASSIC | 04/17/2014 |
| K051344 | ULTIMATE CONCEPTS, INC. | COLONIC AND ENEMA NOZZLE | 08/18/2005 |
| K033149 | ULTIMATE CONCEPTS, INC. | ULTIMATE PROFESSIONAL CONTINUOUS FLOW COLONIC SYSTEM | 03/23/2004 |
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