K090576 is an FDA 510(k) clearance for the FOOTPRINT URINARY DRAINAGE CATHETER, a Catheter, Straight (Class II — Special Controls, product code EZD), submitted by Footprint Medical (San Antonio, US). The FDA issued a Cleared decision on August 12, 2009, 162 days after receiving the submission on March 3, 2009. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5130.
| 510(k) Number | K090576 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 03, 2009 |
| Decision Date | August 12, 2009 |
| Days to Decision | 162 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | EZD — Catheter, Straight |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.5130 |