K131852 is an FDA 510(k) clearance for the HC-1 AND HC-1 CLASSIC. This device is classified as a Colonic Irrigation System (Class II - Special Controls, product code KPL).
Submitted by Transcendencias Comerciales SL Transcom (San Sebastian, Guipuzcoa, ES). The FDA issued a Cleared decision on April 17, 2014, 300 days after receiving the submission on June 21, 2013.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5220.
| 510(k) Number | K131852 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 21, 2013 |
| Decision Date | April 17, 2014 |
| Days to Decision | 300 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | KPL — Colonic Irrigation System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5220 |