K230400 is an FDA 510(k) clearance for the Cure Catheter Closed System; Cure Dextra Closed System, a Catheter, Straight (Class II — Special Controls, product code EZD), submitted by Convatec, Inc. (Greensboro, US). The FDA issued a Cleared decision on November 8, 2023, 266 days after receiving the submission on February 15, 2023. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5130.
| 510(k) Number | K230400 FDA.gov |
| FDA Decision | Cleared SESK |
| Date Received | February 15, 2023 |
| Decision Date | November 08, 2023 |
| Days to Decision | 266 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 |