K241734 is an FDA 510(k) clearance for the Wellead® Hydrophilic Intermittent Catheter Ready to Use. This device is classified as a Catheter, Urethral (Class II - Special Controls, product code GBM).
Submitted by Well Lead Medical Co., Ltd. (Guangzhou, CN). The FDA issued a Cleared decision on March 5, 2025, 261 days after receiving the submission on June 17, 2024.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5130.
| 510(k) Number | K241734 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 17, 2024 |
| Decision Date | March 05, 2025 |
| Days to Decision | 261 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | GBM - Catheter, Urethral |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5130 |