Panels › Gastroenterology, Urology › Product code KPL · Class 2
Colonic Irrigation System
Regulation 876.5220
0510(k)s in 12 months (40 all time)
2recalls in 12 months (2 all time)
0recalls that name a 510(k)
Top companies in KPL
| Company | 510(k)s | Recalls |
|---|---|---|
| Colon Therapeutics | 8 | 0 |
| Tiller Mind Body, Inc. | 3 | 0 |
| Clearwater Colon Hydrotherapy, Inc. | 2 | 0 |
| Edermy LLC | 0 | 2 |
| Gentle Colonics, Inc. | 2 | 0 |
| Prime Pacific Health Innovations Corporation | 2 | 0 |
| Ultimate Concepts, Inc. | 2 | 0 |
| 3M Health Care, Sarns | 1 | 0 |
| Atlantic Health Group | 1 | 0 |
| Clearwater Products, LLC | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 2, 2022 | K201861 | Bio Fluff System Gnali Bocia S.R.L., IT | KPL |
| Jun 1, 2018 | K180800 | Colonic Plus Regular, Small, and Straight Shape Hydrokit Colonic Plus | KPL |
| Aug 10, 2016 | K152834 | Colonplus Colonkit small, Colonplus Colonkit large, Colonplus Colonkit with Stop Collar 6, Colonplus Colonkit with Stop Colonplus Equipments & Speculums, S.L., ES | KPL |
| Sep 11, 2015 | K150381 | AQUA CLEANSE Quality Medical Supply, Inc. | KPL |
| Apr 17, 2014 | K131852 | HC-1 AND HC-1 CLASSIC Transcendencias Comerciales SL Transcom, ES | KPL |
| Jun 11, 2010 | K094022 | THE WATER LILY Clearwater Products, LLC | KPL |
| Oct 5, 2007 | K071057 | COLONIC & ENEMA NOZZLE Tiller Mind Body, Inc. | KPL |
| Aug 18, 2005 | K051344 | COLONIC AND ENEMA NOZZLE Ultimate Concepts, Inc. | KPL |
| Jul 14, 2005 | K050992 | CONMED IRRIGATION NOZZLE Conmedcorp | KPL |
| Mar 15, 2005 | K050112 | PRO FIT DISPOSABLE RECTAL SPECULUM, MODELS 8116 AND 8117 Prime Pacific Health Innovations Corporation, CA | KPL |
| Mar 23, 2004 | K033149 | ULTIMATE PROFESSIONAL CONTINUOUS FLOW COLONIC SYSTEM Ultimate Concepts, Inc. | KPL |
| Jun 27, 2002 | K003720 | ANGEL OF WATER COLON HYDROTHERAPY SYSTEM Lifestream Purfication Systems, LLC | KPL |
| Feb 6, 2002 | K002102 | GENTLE COLONICS IRRIGATION SYSTEM Gentle Colonics, Inc. | KPL |
| Sep 10, 2001 | K000031 | AQUANET, MODEL EC 2000 Prime Pacific Health Innovations Corporation, CA | KPL |
| Aug 8, 2000 | K000388 | CLEARWATER COLON HYDROTHERAPY (DISPOSABLE SPECULUM SPO1 LARGE & SP02 SMALL) Clearwater Colon Hydrotherapy, Inc. | KPL |
| Aug 6, 1998 | K980868 | GC IRRIGATOR Gentle Colonics, Inc. | KPL |
| Oct 31, 1997 | K970482 | TRANSCOM COLON HYDROTHERAPY MODEL HC-2000 Srs Intl. | KPL |
| Sep 29, 1997 | K973256 | JIMMY JOHN III RECTAL NOZZLE Colon Therapeutics | KPL |
| Sep 9, 1997 | K972455 | JIMMY JOHN III RECTAL NOZZEL, MODEL CIT Colon Therapeutics | KPL |
| Aug 29, 1996 | K962259 | LIBBE RECTAL TUBE (FORMERLY A YANKAUER SUCTION TUBE) Tiller Mind Body, Inc. | KPL |
| Jun 26, 1996 | K942867 | CLEARWATER COLON HYDROTHERAPY MODEL PPC-101 Clearwater Colon Hydrotherapy, Inc. | KPL |
| Oct 12, 1995 | K941279 | LOWER BOWEL EVACUATION SYSTEM Tiller Mind Body, Inc. | KPL |
| Dec 24, 1990 | K902993 | SYSTEMS FLOW 2000 Universal Hydrotech, Inc. | KPL |
| Oct 13, 1989 | K894209 | ENEMA KIT Ledins Herbal Healing Systems | KPL |
| Aug 3, 1989 | K891585 | HYDRO-SAN COLONIC IRRIGATION SYSTEM Specialty Health Products, Inc. | KPL |
| Jun 22, 1989 | K893531 | CUFF SPECULUM Mountain Medical Equipment, Inc. | KPL |
| Mar 10, 1989 | K885092 | BARIUM ENEMA TUBES: NO. 3001000, 3001001, 3001002 Medical Imaging Systems, Inc. | KPL |
| Jul 20, 1988 | K881720 | JIMMY JOHN III Colon Therapeutics | KPL |
| Oct 14, 1987 | K873948 | MODIFIED RECTAL NOZZLE Colon Therapeutics | KPL |
| Jun 18, 1987 | K870534 | DOTOLO COLON HYDROTHERAPY INSTRUMENT Dotolo Research Corp. C/O Keller and Heckman | KPL |
| Mar 17, 1987 | K870376 | JIMMY JOHN III, COLONIC IRRIGATION SYSTEM Colon Therapeutics | KPL |
| Mar 17, 1987 | K870127 | MODIFIED JIMMY JOHN III Colon Therapeutics | KPL |
| Oct 16, 1986 | K863539 | HYDRO-CLENZ UNIT Atlantic Health Group | KPL |
| May 15, 1986 | K860943 | JIMMY JOHN III, RECTAL NOZZLE (MODIFICATION) Colon Therapeutics | KPL |
| Oct 24, 1984 | K842083 | JIMMY JOHN III Colon Therapeutics | KPL |
| Jul 17, 1984 | K840613 | COLON IRRIGATION UNIT Colenz Co. | KPL |
| Dec 31, 1980 | K803105 | SARNS INFANT ARTERIAL BUBBLE SENSOR 3M Health Care, Sarns | KPL |
| Jun 26, 1980 | K800565 | HESSLER COLON THERAPY DEVICE Hessler Mfg. Co. | KPL |
| Aug 3, 1979 | K781923 | NON-RETENTION ENEMA SYSTEM Hudson Kendale Assoc., Inc. | KPL |
| Aug 18, 1977 | K770966 | INTERNAL ECOLOGY MACHINE Holistic Equipment, Inc. | KPL |
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