K190312 is an FDA 510(k) clearance for the Dornier Ureteral Stent. This device is classified as a Stent, Ureteral (Class II - Special Controls, product code FAD).
Submitted by Dornier Medtech America, Inc. (Kennesaw, US). The FDA issued a Cleared decision on November 15, 2019, 276 days after receiving the submission on February 12, 2019.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.4620.
| 510(k) Number | K190312 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 12, 2019 |
| Decision Date | November 15, 2019 |
| Days to Decision | 276 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FAD — Stent, Ureteral |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.4620 |