Product code KPL
- Device name
- Colonic Irrigation System
- Medical specialty
- Gastroenterology, Urology
- Device class
- 2
- Regulation number
- 876.5220
- Review panel
- GU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K201861 | Bio Fluff System | Gnali Bocia S.R.L. | 2022-03-02 |
| K180800 | Colonic Plus Regular, Small, and Straight Shape Hydrokit | Colonic Plus | 2018-06-01 |
| K152834 | Colonplus Colonkit small, Colonplus Colonkit large, Colonplus Colonkit with Stop Collar 6, Colonplus Colonkit with Stop Collar 10 | Colonplus Equipments & Speculums, S.L. | 2016-08-10 |
| K150381 | AQUA CLEANSE | Quality Medical Supply, Inc. | 2015-09-11 |
| K131852 | HC-1 AND HC-1 CLASSIC | Transcendencias Comerciales SL Transcom | 2014-04-17 |
| K094022 | THE WATER LILY | Clearwater Products, LLC | 2010-06-11 |
| K071057 | COLONIC & ENEMA NOZZLE | Tiller Mind Body, Inc. | 2007-10-05 |
| K051344 | COLONIC AND ENEMA NOZZLE | Ultimate Concepts, Inc. | 2005-08-18 |
| K050992 | CONMED IRRIGATION NOZZLE | Conmedcorp | 2005-07-14 |
| K050112 | PRO FIT DISPOSABLE RECTAL SPECULUM, MODELS 8116 AND 8117 | Prime Pacific Health Innovations Corporation | 2005-03-15 |
| K033149 | ULTIMATE PROFESSIONAL CONTINUOUS FLOW COLONIC SYSTEM | Ultimate Concepts, Inc. | 2004-03-23 |
| K003720 | ANGEL OF WATER COLON HYDROTHERAPY SYSTEM | Lifestream Purfication Systems, LLC | 2002-06-27 |
| K002102 | GENTLE COLONICS IRRIGATION SYSTEM | Gentle Colonics, Inc. | 2002-02-06 |
| K000031 | AQUANET, MODEL EC 2000 | Prime Pacific Health Innovations Corporation | 2001-09-10 |
| K000388 | CLEARWATER COLON HYDROTHERAPY (DISPOSABLE SPECULUM SPO1 LARGE & SP02 SMALL) | Clearwater Colon Hydrotherapy, Inc. | 2000-08-08 |
| K980868 | GC IRRIGATOR | Gentle Colonics, Inc. | 1998-08-06 |
| K970482 | TRANSCOM COLON HYDROTHERAPY MODEL HC-2000 | Srs Intl. | 1997-10-31 |
| K973256 | JIMMY JOHN III RECTAL NOZZLE | Colon Therapeutics | 1997-09-29 |
| K972455 | JIMMY JOHN III RECTAL NOZZEL, MODEL CIT | Colon Therapeutics | 1997-09-09 |
| K962259 | LIBBE RECTAL TUBE (FORMERLY A YANKAUER SUCTION TUBE) | Tiller Mind Body, Inc. | 1996-08-29 |
| K942867 | CLEARWATER COLON HYDROTHERAPY MODEL PPC-101 | Clearwater Colon Hydrotherapy, Inc. | 1996-06-26 |
| K941279 | LOWER BOWEL EVACUATION SYSTEM | Tiller Mind Body, Inc. | 1995-10-12 |
| K902993 | SYSTEMS FLOW 2000 | Universal Hydrotech, Inc. | 1990-12-24 |
| K894209 | ENEMA KIT | Ledins Herbal Healing Systems | 1989-10-13 |
| K891585 | HYDRO-SAN COLONIC IRRIGATION SYSTEM | Specialty Health Products, Inc. | 1989-08-03 |
| K893531 | CUFF SPECULUM | Mountain Medical Equipment, Inc. | 1989-06-22 |
| K885092 | BARIUM ENEMA TUBES: NO. 3001000, 3001001, 3001002 | Medical Imaging Systems, Inc. | 1989-03-10 |
| K881720 | JIMMY JOHN III | Colon Therapeutics | 1988-07-20 |
| K873948 | MODIFIED RECTAL NOZZLE | Colon Therapeutics | 1987-10-14 |
| K870534 | DOTOLO COLON HYDROTHERAPY INSTRUMENT | Dotolo Research Corp. C/O Keller and Heckman | 1987-06-18 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| B149CM11 | Angel of Water | LIFESTREAM PURIFICATION SYSTEM LLC | 2023-12-11 |
| 10868538000414 | LIBBE Colonic Nozzle | Mind Body Naturopathic Inst | 2021-04-30 |
| 00868538000417 | LIBBE Colonic Nozzle | Mind Body Naturopathic Inst | 2021-04-30 |
| 00850014947163 | QMS - AQUA CLEANSE | QUALITY MEDICAL SUPPLY, INC. | 2019-12-12 |
| B149SP00011 | Colon Cleansing Nozzle with Flex Tube | LIFESTREAM PURIFICATION SYSTEM LLC | 2017-02-10 |
| B149SP0001 | Colon Cleansing Nozzle with Flex Tube | LIFESTREAM PURIFICATION SYSTEM LLC | 2017-02-10 |
| B482Z200 | Colonic Irrigation Kit | TRANSCENDENCIAS COMERCIALES SL | 2016-12-29 |
| B482Z170 | Colonic Irrigation Kit | TRANSCENDENCIAS COMERCIALES SL | 2016-12-29 |
| B482Z160 | Colonic Irrigation Kit | TRANSCENDENCIAS COMERCIALES SL | 2016-12-29 |
| B482Z100 | Colonic irrigation Kit | TRANSCENDENCIAS COMERCIALES SL | 2016-12-29 |
| B482Z090 | Colonic Irrigation Kit | TRANSCENDENCIAS COMERCIALES SL | 2016-12-29 |
| B482HC2000C0 | Colonic Lavage Unit | TRANSCENDENCIAS COMERCIALES SL | 2016-12-29 |
| B482HC1C0 | Colonic Lavage Unit | TRANSCENDENCIAS COMERCIALES SL | 2016-12-29 |
| B482HC10 | Colonic Lavage Unit | TRANSCENDENCIAS COMERCIALES SL | 2016-12-29 |
| B4249244480 | Colonic Irrigation Kit | CLEARWATER COLON HYDROTHERAPY, INC. | 2016-09-24 |
| B424400101 | Colonic Lavage System | CLEARWATER COLON HYDROTHERAPY, INC. | 2016-09-24 |
| B4249244420 | Colonic Irrigation Kit | CLEARWATER COLON HYDROTHERAPY, INC. | 2016-09-24 |
| B4249234480 | Colonic Irrigation Kit | CLEARWATER COLON HYDROTHERAPY, INC. | 2016-09-24 |
| B4249234420 | Colonic Irrigation Kit | CLEARWATER COLON HYDROTHERAPY, INC. | 2016-09-24 |
| B4249224480 | Colonic Irrigation Kit | CLEARWATER COLON HYDROTHERAPY, INC. | 2016-09-24 |
| B4249224420 | Colonic Irrigation Kit | CLEARWATER COLON HYDROTHERAPY, INC. | 2016-09-24 |
| B4249214480 | Colonic Irrigation Kit | CLEARWATER COLON HYDROTHERAPY, INC. | 2016-09-24 |
| B4249214420 | Colonic Irrigation Kit | CLEARWATER COLON HYDROTHERAPY, INC. | 2016-09-24 |
| B4247204000 | Colonic Irrigation Nozzle | CLEARWATER COLON HYDROTHERAPY, INC. | 2016-09-24 |
| B4247203000 | Colonic Irrigation Nozzle | CLEARWATER COLON HYDROTHERAPY, INC. | 2016-09-24 |
| B4247202000 | Colonic Irrigation Nozzle | CLEARWATER COLON HYDROTHERAPY, INC. | 2016-09-24 |
| B4247201000 | Colonic Irrigation Nozzle | CLEARWATER COLON HYDROTHERAPY, INC. | 2016-09-24 |
| B4244002010 | Colonic Lavage System | CLEARWATER COLON HYDROTHERAPY, INC. | 2016-09-24 |
| B4244001510 | Colonic Lavage System | CLEARWATER COLON HYDROTHERAPY, INC. | 2016-09-24 |
| B4244001010 | Colonic Lavage System | CLEARWATER COLON HYDROTHERAPY, INC. | 2016-09-24 |