Gentle Colonics Irrigation System
FDA 510(k) K002102 · Gentle Colonics, Inc.
510(k) numberK002102
Submission
- Device name
- Gentle Colonics Irrigation System
- Applicant
- Gentle Colonics, Inc.
Irvine, CA, US - Received
- July 12, 2000
- Decision date
- February 6, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
| K152834 | Colonplus Colonkit small, Colonplus Colonkit large, Colonplus Colonkit with Stop Collar…KPL · Traditional | Colonplus Equipments & Speculums, S.L. | 08/10/2016SE |
| 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 |
More from Prime Pacific Health Innovations Corporation
| 510(k) | Device | Decision |
|---|---|---|
| K980868 | GC IrrigatorKPL · Traditional | 08/06/1998SE |
Questions and answers
When was Gentle Colonics Irrigation System cleared by the FDA?
Gentle Colonics Irrigation System (K002102) received a 510(k) decision of Substantially Equivalent on February 6, 2002, 574 days after the submission was received.
What is the product code of K002102?
The FDA product code is KPL – Colonic Irrigation System, a Class II (moderate risk) device regulated under 21 CFR 876.5220.