K150550 is an FDA 510(k) clearance for the SilverCoat Silicone Foley Catheter, a Catheter, Retention Type, Balloon (Class II — Special Controls, product code EZL), submitted by Covalontechnologies, Inc. (Mississauga, CA). The FDA issued a Cleared decision on November 24, 2015, 266 days after receiving the submission on March 3, 2015. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5130.
| 510(k) Number | K150550 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 03, 2015 |
| Decision Date | November 24, 2015 |
| Days to Decision | 266 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 |