K233101 is an FDA 510(k) clearance for the Luja Coude (20108 Male CH18 - large packaging). 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 October 26, 2023, 30 days after receiving the submission on September 26, 2023.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5130.
| 510(k) Number | K233101 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 26, 2023 |
| Decision Date | October 26, 2023 |
| Days to Decision | 30 days |
| Submission Type | Special |
| 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 |