K140310 is an FDA 510(k) clearance for the Peristeen Anal Irrigation System. This device is classified as a Tubes, Gastrointestinal (and Accessories) (Class II - Special Controls, product code KNT).
Submitted by Coloplast A/S (Minneapolis, US). The FDA issued a Cleared decision on September 3, 2015, 573 days after receiving the submission on February 7, 2014.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5980.
| 510(k) Number | K140310 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 07, 2014 |
| Decision Date | September 03, 2015 |
| Days to Decision | 573 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | KNT — Tubes, Gastrointestinal (and Accessories) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5980 |