FDA Product Code
FDA Product Code KPL — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.5220
510(k) Clearances — 40 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K201861 | Bio Fluff System | Gnali Bocia S.R.L. | 2022-03-02 | Traditional | PDF ↗ |
| K180800 | Colonic Plus Regular, Small, and Straight Shape Hydrokit | Colonic Plus | 2018-06-01 | Traditional | PDF ↗ |
| 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 | Traditional | PDF ↗ |
| K150381 | AQUA CLEANSE | Quality Medical Supply, Inc. | 2015-09-11 | Traditional | PDF ↗ |
| K131852 | HC-1 AND HC-1 CLASSIC | Transcendencias Comerciales SL Transcom | 2014-04-17 | Traditional | PDF ↗ |
| K094022 | THE WATER LILY | Clearwater Products, LLC | 2010-06-11 | Traditional | PDF ↗ |
| K071057 | COLONIC & ENEMA NOZZLE | Tiller Mind Body, Inc. | 2007-10-05 | Traditional | PDF ↗ |
| K051344 | COLONIC AND ENEMA NOZZLE | Ultimate Concepts, Inc. | 2005-08-18 | Special | PDF ↗ |
| K050992 | CONMED IRRIGATION NOZZLE | Conmedcorp | 2005-07-14 | Traditional | PDF ↗ |
| K050112 | PRO FIT DISPOSABLE RECTAL SPECULUM, MODELS 8116 AND 8117 | Prime Pacific Health Innovations Corporation | 2005-03-15 | Traditional | PDF ↗ |
| K033149 | ULTIMATE PROFESSIONAL CONTINUOUS FLOW COLONIC SYSTEM | Ultimate Concepts, Inc. | 2004-03-23 | Traditional | PDF ↗ |
| K003720 | ANGEL OF WATER COLON HYDROTHERAPY SYSTEM | Lifestream Purfication Systems, LLC | 2002-06-27 | Traditional | PDF ↗ |
| K002102 | GENTLE COLONICS IRRIGATION SYSTEM | Gentle Colonics, Inc. | 2002-02-06 | Traditional | PDF ↗ |
| K000031 | AQUANET, MODEL EC 2000 | Prime Pacific Health Innovations Corporation | 2001-09-10 | Traditional | PDF ↗ |
| K000388 | CLEARWATER COLON HYDROTHERAPY (DISPOSABLE SPECULUM SPO1 LARGE & SP02 SMALL) | Clearwater Colon Hydrotherapy, Inc. | 2000-08-08 | Traditional | PDF ↗ |
| K980868 | GC IRRIGATOR | Gentle Colonics, Inc. | 1998-08-06 | Traditional | PDF ↗ |
| K970482 | TRANSCOM COLON HYDROTHERAPY MODEL HC-2000 | Srs Intl. | 1997-10-31 | Traditional | PDF ↗ |
| K973256 | JIMMY JOHN III RECTAL NOZZLE | Colon Therapeutics | 1997-09-29 | Traditional | PDF ↗ |
| K972455 | JIMMY JOHN III RECTAL NOZZEL, MODEL CIT | Colon Therapeutics | 1997-09-09 | Traditional | PDF ↗ |
| K962259 | LIBBE RECTAL TUBE (FORMERLY A YANKAUER SUCTION TUBE) | Tiller Mind Body, Inc. | 1996-08-29 | Traditional | PDF ↗ |
| K942867 | CLEARWATER COLON HYDROTHERAPY MODEL PPC-101 | Clearwater Colon Hydrotherapy, Inc. | 1996-06-26 | Traditional | PDF ↗ |
| K941279 | LOWER BOWEL EVACUATION SYSTEM | Tiller Mind Body, Inc. | 1995-10-12 | Traditional | PDF ↗ |
| K902993 | SYSTEMS FLOW 2000 | Universal Hydrotech, Inc. | 1990-12-24 | Traditional | PDF ↗ |
| K894209 | ENEMA KIT | Ledins Herbal Healing Systems | 1989-10-13 | Traditional | PDF ↗ |
| K891585 | HYDRO-SAN COLONIC IRRIGATION SYSTEM | Specialty Health Products, Inc. | 1989-08-03 | Traditional | PDF ↗ |
| K893531 | CUFF SPECULUM | Mountain Medical Equipment, Inc. | 1989-06-22 | Traditional | PDF ↗ |
| K885092 | BARIUM ENEMA TUBES: NO. 3001000, 3001001, 3001002 | Medical Imaging Systems, Inc. | 1989-03-10 | Traditional | PDF ↗ |
| K881720 | JIMMY JOHN III | Colon Therapeutics | 1988-07-20 | Traditional | PDF ↗ |
| K873948 | MODIFIED RECTAL NOZZLE | Colon Therapeutics | 1987-10-14 | Traditional | PDF ↗ |
| K870534 | DOTOLO COLON HYDROTHERAPY INSTRUMENT | Dotolo Research Corp. C/O Keller and Heckman | 1987-06-18 | Traditional | PDF ↗ |
| K870127 | MODIFIED JIMMY JOHN III | Colon Therapeutics | 1987-03-17 | Traditional | PDF ↗ |
| K870376 | JIMMY JOHN III, COLONIC IRRIGATION SYSTEM | Colon Therapeutics | 1987-03-17 | Traditional | PDF ↗ |
| K863539 | HYDRO-CLENZ UNIT | Atlantic Health Group | 1986-10-16 | Traditional | PDF ↗ |
| K860943 | JIMMY JOHN III, RECTAL NOZZLE (MODIFICATION) | Colon Therapeutics | 1986-05-15 | Traditional | PDF ↗ |
| K842083 | JIMMY JOHN III | Colon Therapeutics | 1984-10-24 | Traditional | PDF ↗ |
| K840613 | COLON IRRIGATION UNIT | Colenz Co. | 1984-07-17 | Traditional | PDF ↗ |
| K803105 | SARNS INFANT ARTERIAL BUBBLE SENSOR | 3M Health Care, Sarns | 1980-12-31 | Traditional | PDF ↗ |
| K800565 | HESSLER COLON THERAPY DEVICE | Hessler Mfg. Co. | 1980-06-26 | Traditional | PDF ↗ |
| K781923 | NON-RETENTION ENEMA SYSTEM | Hudson Kendale Assoc., Inc. | 1979-08-03 | Traditional | PDF ↗ |
| K770966 | INTERNAL ECOLOGY MACHINE | Holistic Equipment, Inc. | 1977-08-18 | Traditional | PDF ↗ |
Product code KPL · Class II · Gastroenterology, Urology. Data: openFDA.