K241028 is an FDA 510(k) clearance for the Luja female (20051); Luja female (20052); Luja female (20054); Luja female (20056), a Catheter, Straight (Class II — Special Controls, product code EZD), submitted by Coloplast (Plymouth, US). The FDA issued a Cleared decision on July 26, 2024, 102 days after receiving the submission on April 15, 2024. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5130.
| 510(k) Number | K241028 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 15, 2024 |
| Decision Date | July 26, 2024 |
| Days to Decision | 102 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 |