K170531 is an FDA 510(k) clearance for the Ureteral Dilators and Percutaneous Nephrostomy Dilators. This device is classified as a Dilator, Catheter, Ureteral (Class II - Special Controls, product code EZN).
Submitted by Coloplast Corp. (Plymouth, US). The FDA issued a Cleared decision on August 17, 2017, 176 days after receiving the submission on February 22, 2017.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5470.
| 510(k) Number | K170531 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 22, 2017 |
| Decision Date | August 17, 2017 |
| Days to Decision | 176 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 |