Colonplus Colonkit small, Colonplus Colonkit large, Colonplus Colonkit with Stop Collar 6, Colonplus Colonkit with Stop Collar 10
FDA 510(k) K152834 · Colonplus Equipments & Speculums, S.L.
510(k) numberK152834
Submission
- 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.
San Sebastian (Guipuzcoa), ES - Received
- September 29, 2015
- Decision date
- August 10, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KPL – Colonic Irrigation System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5220
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code KPL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K201861 | Bio Fluff SystemKPL · Traditional | Gnali Bocia S.R.L. | 03/02/2022SE |
| K180800 | Colonic Plus Regular, Small, and Straight Shape HydrokitKPL · Traditional | Colonic Plus | 06/01/2018SESK |
| K150381 | Aqua CleanseKPL · Traditional | Quality Medical Supply, Inc. | 09/11/2015SE |
| K131852 | HC-1 and HC-1 ClassicKPL · Traditional | Transcendencias Comerciales SL Transcom | 04/17/2014SE |
| K094022 | The Water LilyKPL · Traditional | Clearwater Products, LLC | 06/11/2010SE |
| K071057 | Colonic & Enema NozzleKPL · Traditional | Tiller Mind Body, Inc. | 10/05/2007SE |
| K051344 | Colonic and Enema NozzleKPL · Special | Ultimate Concepts, Inc. | 08/18/2005SE |
| K050992 | Conmed Irrigation NozzleKPL · Traditional | Conmedcorp | 07/14/2005SE |
| K050112 | Pro Fit Disposable Rectal Speculum, Models 8116 and 8117KPL · Traditional | Prime Pacific Health Innovations Corporation | 03/15/2005SE |
| K033149 | Ultimate Professional Continuous Flow Colonic SystemKPL · Traditional | Ultimate Concepts, Inc. | 03/23/2004SE |
Questions and answers
When was Colonplus Colonkit small, Colonplus Colonkit large, Colonplus Colonkit with Stop Collar 6, Colonplus Colonkit with Stop Collar 10 cleared by the FDA?
Colonplus Colonkit small, Colonplus Colonkit large, Colonplus Colonkit with Stop Collar 6, Colonplus Colonkit with Stop Collar 10 (K152834) received a 510(k) decision of Substantially Equivalent on August 10, 2016, 316 days after the submission was received.
What is the product code of K152834?
The FDA product code is KPL – Colonic Irrigation System, a Class II (moderate risk) device regulated under 21 CFR 876.5220.