510(k) K152834
- Device
- Colonplus Colonkit Small, Colonplus Colonkit Large, Colonplus Colonkit With Stop Collar 6, Colonplus Colonkit With Stop Collar 10
- Applicant
- COLONPLUS EQUIPMENTS & SPECULUMS, S.L.
- 510(k) number
- K152834
- Product code
- KPL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2016-08-10
- Date received
- 2015-09-29
- Regulation
- 876.5220
- Classification name
- Colonic Irrigation System
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Jorge Echevarria
- Address
- C/Portuetxe 13, 1 C 20018 San Sebastian (Guipuzcoa) ES
FDA Registration Numbers#
- 3042228064
- 2027347
- 2433012
- 3022964615
- 3043012240
- 9615415
- 1648139
- 3005346382
- 1223925
- 3007305485
- 3043011436
- 1062839
- 3043012074
- 1320894
Source Documents#
Other 510(k) Records For Product Code KPL #
| 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 |
| 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 |
Legacy Summary#
summary
FDA Review#
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