K251178 is an FDA 510(k) clearance for the Ready to use Nelaton Catheter. This device is classified as a Catheter, Straight (Class II - Special Controls, product code EZD).
Submitted by Jamjoom Fullcare Corporation (Shaoxing, CN). The FDA issued a Cleared decision on January 2, 2026, 261 days after receiving the submission on April 16, 2025.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5130.
| 510(k) Number | K251178 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 16, 2025 |
| Decision Date | January 02, 2026 |
| Days to Decision | 261 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 |