K243175 is an FDA 510(k) clearance for the Disposable Intermittent Catheter (TPU Catheter). This device is classified as a Catheter, Straight (Class II - Special Controls, product code EZD).
Submitted by Chengdu Daxan Innovative Medical Tech. Co., Ltd. (Chengdu, CN). The FDA issued a Cleared decision on June 26, 2025, 269 days after receiving the submission on September 30, 2024.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5130.
| 510(k) Number | K243175 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 30, 2024 |
| Decision Date | June 26, 2025 |
| Days to Decision | 269 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 |