K223626 is an FDA 510(k) clearance for the Niti-S Biliary Speed D Stent, a Stents, Drains And Dilators For The Biliary Ducts (Class II — Special Controls, product code FGE), submitted by Taewoong Medical Co., Ltd. (Gimpo-Si, KR). The FDA issued a Cleared decision on May 26, 2023, 172 days after receiving the submission on December 5, 2022. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5010.
| 510(k) Number | K223626 FDA.gov |
| FDA Decision | Cleared SESU |
| Date Received | December 05, 2022 |
| Decision Date | May 26, 2023 |
| Days to Decision | 172 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FGE — Stents, Drains And Dilators For The Biliary Ducts |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.5010 |