K180028 is an FDA 510(k) clearance for the Cook 810 Set, Desilets-Hoffman Introducer 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 May 2, 2018, 119 days after receiving the submission on January 3, 2018.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5470.
| 510(k) Number | K180028 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 03, 2018 |
| Decision Date | May 02, 2018 |
| Days to Decision | 119 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 |