K172588 is an FDA 510(k) clearance for the Balloon Catheter and Balloon Ureteral Dilator Set. This device is classified as a Dilator, Catheter, Ureteral (Class II - Special Controls, product code EZN).
Submitted by Cook Incorporated (Bloomington, US). The FDA issued a Cleared decision on April 19, 2018, 233 days after receiving the submission on August 29, 2017.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5470.
| 510(k) Number | K172588 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Special 510(k) (SESK) |
| Date Received | August 29, 2017 |
| Decision Date | April 19, 2018 |
| Days to Decision | 233 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 |