K250663 is an FDA 510(k) clearance for the Niti-S Duodenal Comfort Stent, Niti-S Colonic Comfort Stent. This device is classified as a Stent, Metallic, Expandable, Duodenal (Class II - Special Controls, product code MUM).
Submitted by Taewoong Medical Co., Ltd. (Gyeonggi-Do, KR). The FDA issued a Cleared decision on March 31, 2025, 26 days after receiving the submission on March 5, 2025.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 878.3610.
| 510(k) Number | K250663 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 05, 2025 |
| Decision Date | March 31, 2025 |
| Days to Decision | 26 days |
| Submission Type | Special |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | MUM — Stent, Metallic, Expandable, Duodenal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.3610 |