K051059 is an FDA 510(k) clearance for the AMSURE 100% SILICONE FOLEY CATHETER. This device is classified as a Catheter, Retention Type, Balloon (Class II - Special Controls, product code EZL).
Submitted by Amsino International, Inc. (Pomona, US). The FDA issued a Cleared decision on June 28, 2005, 63 days after receiving the submission on April 26, 2005.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5130.
| 510(k) Number | K051059 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 26, 2005 |
| Decision Date | June 28, 2005 |
| Days to Decision | 63 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 |