HC-1 and HC-1 Classic
FDA 510(k) K131852 · Transcendencias Comerciales SL Transcom
510(k) numberK131852
Submission
- Device name
- HC-1 and HC-1 Classic
- Applicant
- Transcendencias Comerciales SL Transcom
San Sebastian, Guipuzcoa, ES - Received
- June 21, 2013
- Decision date
- April 17, 2014
- 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 |
| 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 |
| 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 HC-1 and HC-1 Classic cleared by the FDA?
HC-1 and HC-1 Classic (K131852) received a 510(k) decision of Substantially Equivalent on April 17, 2014, 300 days after the submission was received.
What is the product code of K131852?
The FDA product code is KPL – Colonic Irrigation System, a Class II (moderate risk) device regulated under 21 CFR 876.5220.