K092250 is an FDA 510(k) clearance for the MEDLINE RED RUBBER URETHRAL CATHETER. This device is classified as a Catheter, Ureteral, Gastro-urology (Class II - Special Controls, product code EYB).
Submitted by Medline Industries, Inc. (Mundelein, US). The FDA issued a Cleared decision on January 21, 2010, 177 days after receiving the submission on July 28, 2009.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5130.
| 510(k) Number | K092250 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 28, 2009 |
| Decision Date | January 21, 2010 |
| Days to Decision | 177 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 |