K241028 is an FDA 510(k) clearance for the Luja female (20051). This device is classified as 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 FDA review panel. Regulated under 21 CFR 876.5130.
| 510(k) Number | K241028 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (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 |