K213185 is an FDA 510(k) clearance for the ImaJin Silicone double loop ureteral stent kits, ImaJin Pyelostent Silicone double loop ureteral stent kits, ImaJin Stenostent Silicone double loop ureteral stent kits. This device is classified as a Stent, Ureteral (Class II - Special Controls, product code FAD).
Submitted by Coloplast Corp. (Plymouth, US). The FDA issued a Cleared decision on June 8, 2022, 252 days after receiving the submission on September 29, 2021.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.4620.
| 510(k) Number | K213185 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Special 510(k) (SESK) |
| Date Received | September 29, 2021 |
| Decision Date | June 08, 2022 |
| Days to Decision | 252 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 |