K040897 is an FDA 510(k) clearance for the DOVER ROB-NEL CATHETER, a Catheter, Urological (Class II — Special Controls, product code KOD), submitted by Tyco Healthcare (Mansfield, US). The FDA issued a Cleared decision on July 20, 2004, 105 days after receiving the submission on April 6, 2004. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5130.
| 510(k) Number | K040897 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 06, 2004 |
| Decision Date | July 20, 2004 |
| Days to Decision | 105 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | KOD — Catheter, Urological |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.5130 |