Colonplus Colonkit small, Colonplus Colonkit large, Colonplus Colonkit with Stop Collar 6, Colonplus Colonkit with Stop Collar 10
FDA 510(k) clearance K152834 · decided 2016-08-10
Clearance details
- K-number
- K152834
- Device name
- Colonplus Colonkit small, Colonplus Colonkit large, Colonplus Colonkit with Stop Collar 6, Colonplus Colonkit with Stop Collar 10
- Applicant
- Colonplus Equipments & Speculums, S.L.
- Decision
- Substantially Equivalent
- Date received
- 2015-09-29
- Decision date
- 2016-08-10
- Days to decision
- 316 days
- Clearance type
- Traditional
- Product code
- KPL
- Device class
- 2
- Regulation number
- 876.5220
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- San Sebastian (Guipuzcoa), ES
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Bio Fluff System (K201861) | Gnali Bocia S.R.L. | 2022-03-02 |
| Colonic Plus Regular, Small, and Straight Shape Hydrokit (K180800) | Colonic Plus | 2018-06-01 |
| AQUA CLEANSE (K150381) | Quality Medical Supply, Inc. | 2015-09-11 |
| HC-1 AND HC-1 CLASSIC (K131852) | Transcendencias Comerciales SL Transcom | 2014-04-17 |
| THE WATER LILY (K094022) | Clearwater Products, LLC | 2010-06-11 |
| COLONIC & ENEMA NOZZLE (K071057) | Tiller Mind Body, Inc. | 2007-10-05 |
| COLONIC AND ENEMA NOZZLE (K051344) | Ultimate Concepts, Inc. | 2005-08-18 |
| CONMED IRRIGATION NOZZLE (K050992) | Conmedcorp | 2005-07-14 |
| PRO FIT DISPOSABLE RECTAL SPECULUM, MODELS 8116 AND 8117 (K050112) | Prime Pacific Health Innovations Corporation | 2005-03-15 |
| ULTIMATE PROFESSIONAL CONTINUOUS FLOW COLONIC SYSTEM (K033149) | Ultimate Concepts, Inc. | 2004-03-23 |
| ANGEL OF WATER COLON HYDROTHERAPY SYSTEM (K003720) | Lifestream Purfication Systems, LLC | 2002-06-27 |
| GENTLE COLONICS IRRIGATION SYSTEM (K002102) | Gentle Colonics, Inc. | 2002-02-06 |
Recalls involving this device
No recalls on record reference this clearance.