K030293 is an FDA 510(k) clearance for the AMSURE RED RUBBER URETHRAL CATHETER. This device is classified as a Catheter, Ureteral, Gastro-urology (Class II - Special Controls, product code EYB).
Submitted by Amsino International, Inc. (Ontario, US). The FDA issued a Cleared decision on February 4, 2004, 372 days after receiving the submission on January 28, 2003.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5130.
| 510(k) Number | K030293 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 28, 2003 |
| Decision Date | February 04, 2004 |
| Days to Decision | 372 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | EYB — Catheter, Ureteral, Gastro-urology |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5130 |