K242049 is an FDA 510(k) clearance for the SureCath Set, a Catheter, Straight (Class II — Special Controls, product code EZD), submitted by Coloplast Corp. (Minneapolis, US). The FDA issued a Cleared decision on November 26, 2024, 137 days after receiving the submission on July 12, 2024. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5130.
| 510(k) Number | K242049 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 12, 2024 |
| Decision Date | November 26, 2024 |
| Days to Decision | 137 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 |