K251116 is an FDA 510(k) clearance for the Luja Coudé. This device is classified as a Catheter, Straight (Class II - Special Controls, product code EZD).
Submitted by Coloplast Corp. (Plymouth, US). The FDA issued a Cleared decision on June 27, 2025, 77 days after receiving the submission on April 11, 2025.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5130.
| 510(k) Number | K251116 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 11, 2025 |
| Decision Date | June 27, 2025 |
| Days to Decision | 77 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | EZD — Catheter, Straight |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5130 |