K212868 is an FDA 510(k) clearance for the JFil Ureteral Stents, JFil Ureteral Stents ECO KIT. This device is classified as a Stent, Ureteral (Class II - Special Controls, product code FAD).
Submitted by Rocamed Sam (Monaco, MC). The FDA issued a Cleared decision on January 26, 2022, 139 days after receiving the submission on September 9, 2021.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.4620.
| 510(k) Number | K212868 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 09, 2021 |
| Decision Date | January 26, 2022 |
| Days to Decision | 139 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 |