K223067 is an FDA 510(k) clearance for the Niti-S Duodenal Stent. This device is classified as a Stent, Metallic, Expandable, Duodenal (Class II - Special Controls, product code MUM).
Submitted by Taewoong Medical Co., Ltd. (Gimpo-Si, KR). The FDA issued a Cleared decision on June 14, 2023, 264 days after receiving the submission on September 23, 2022.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 878.3610.
| 510(k) Number | K223067 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 23, 2022 |
| Decision Date | June 14, 2023 |
| Days to Decision | 264 days |
| Submission Type | Traditional |
| 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 |