K072997 is an FDA 510(k) clearance for the NEOMED URINARY CATHETER, a Catheter, Straight (Class II — Special Controls, product code EZD), submitted by Neomed, Inc. (Swanee, US). The FDA issued a Cleared decision on December 19, 2007, 56 days after receiving the submission on October 24, 2007. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5130.
| 510(k) Number | K072997 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 24, 2007 |
| Decision Date | December 19, 2007 |
| Days to Decision | 56 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | EZD — Catheter, Straight |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.5130 |