K250891 is an FDA 510(k) clearance for the Cure Catheter Insertion Kit (K1). This device is classified as a Tray, Catheterization, Sterile Urethral, With Or Without Catheter (kit) (Class II - Special Controls, product code FCM).
Submitted by Convatec Limited (Flintshire, GB). The FDA issued a Cleared decision on June 6, 2025, 73 days after receiving the submission on March 25, 2025.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5130.
| 510(k) Number | K250891 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Special 510(k) (SESK) |
| Date Received | March 25, 2025 |
| Decision Date | June 06, 2025 |
| Days to Decision | 73 days |
| Submission Type | Special |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FCM - Tray, Catheterization, Sterile Urethral, With Or Without Catheter (kit) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5130 |