KPL — Colonic Irrigation System Class II
FDA product code KPL covers "Colonic Irrigation System", a Class II medical device regulated under 21 CFR 876.5220. Submissions are reviewed by the Gastroenterology, Urology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- KPL
- Device Class
- Class II
- Regulation Number
- 876.5220
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K201861 | gnali bocia | Bio Fluff System | March 2, 2022 |
| K180800 | colonic plus | Colonic Plus Regular, Small, and Straight Shape Hydrokit | June 1, 2018 |
| K152834 | colonplus equipments and speculums, s.l | Colonplus Colonkit small, Colonplus Colonkit large, Colonplus Colonkit with Stop | August 10, 2016 |
| K150381 | quality medical supply | AQUA CLEANSE | September 11, 2015 |
| K131852 | transcendencias comerciales sl transcom | HC-1 AND HC-1 CLASSIC | April 17, 2014 |
| K094022 | clearwater products | THE WATER LILY | June 11, 2010 |
| K071057 | tiller mind body | COLONIC & ENEMA NOZZLE | October 5, 2007 |
| K051344 | ultimate concepts | COLONIC AND ENEMA NOZZLE | August 18, 2005 |
| K050992 | conmedcorp | CONMED IRRIGATION NOZZLE | July 14, 2005 |
| K050112 | prime pacific health innovations corporation | PRO FIT DISPOSABLE RECTAL SPECULUM, MODELS 8116 AND 8117 | March 15, 2005 |
| K033149 | ultimate concepts | ULTIMATE PROFESSIONAL CONTINUOUS FLOW COLONIC SYSTEM | March 23, 2004 |
| K003720 | lifestream purfication systems | ANGEL OF WATER COLON HYDROTHERAPY SYSTEM | June 27, 2002 |
| K002102 | gentle colonics | GENTLE COLONICS IRRIGATION SYSTEM | February 6, 2002 |
| K000031 | prime pacific health innovations corporation | AQUANET, MODEL EC 2000 | September 10, 2001 |
| K000388 | clearwater colon hydrotherapy | CLEARWATER COLON HYDROTHERAPY (DISPOSABLE SPECULUM SPO1 LARGE & SP02 SMALL) | August 8, 2000 |
| K980868 | gentle colonics | GC IRRIGATOR | August 6, 1998 |
| K970482 | srs intl | TRANSCOM COLON HYDROTHERAPY MODEL HC-2000 | October 31, 1997 |
| K973256 | colon therapeutics | JIMMY JOHN III RECTAL NOZZLE | September 29, 1997 |
| K972455 | colon therapeutics | JIMMY JOHN III RECTAL NOZZEL, MODEL CIT | September 9, 1997 |
| K962259 | tiller mind body | LIBBE RECTAL TUBE (FORMERLY A YANKAUER SUCTION TUBE) | August 29, 1996 |