K040127 is an FDA 510(k) clearance for the COOK URETERAL BALLOON DILATION CATHETER SET. This device is classified as a Dilator, Catheter, Ureteral (Class II - Special Controls, product code EZN).
Submitted by Cook Urological, Inc. (Spencer, US). The FDA issued a Cleared decision on April 6, 2004, 76 days after receiving the submission on January 21, 2004.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5470.
| 510(k) Number | K040127 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Special 510(k) (SESK) |
| Date Received | January 21, 2004 |
| Decision Date | April 06, 2004 |
| Days to Decision | 76 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | EZN — Dilator, Catheter, Ureteral |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5470 |