K233411 is an FDA 510(k) clearance for the Folysil Silicone Catheter. This device is classified as a Catheter, Retention Type, Balloon (Class II - Special Controls, product code EZL).
Submitted by Coloplast Corp. (Plymouth, US). The FDA issued a Cleared decision on April 15, 2024, 192 days after receiving the submission on October 6, 2023.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5130.
| 510(k) Number | K233411 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 06, 2023 |
| Decision Date | April 15, 2024 |
| Days to Decision | 192 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | EZL — Catheter, Retention Type, Balloon |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5130 |