K223821 is an FDA 510(k) clearance for the Self-Cath Closed System. This device is classified as a Tray, Catheterization, Sterile Urethral, With Or Without Catheter (kit) (Class II - Special Controls, product code FCM).
Submitted by Coloplast (Plymouth, US). The FDA issued a Cleared decision on August 2, 2023, 224 days after receiving the submission on December 21, 2022.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5130.
| 510(k) Number | K223821 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 21, 2022 |
| Decision Date | August 02, 2023 |
| Days to Decision | 224 days |
| Submission Type | Traditional |
| 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 |