K243619 is an FDA 510(k) clearance for the Niti-S Esophageal Stent; Esophageal TTS Stent, a Prosthesis, Esophageal (Class II — Special Controls, product code ESW), submitted by Taewoong Medical Co., Ltd. (Gyeonggi-Do, KR). The FDA issued a Cleared decision on October 30, 2025, 342 days after receiving the submission on November 22, 2024. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 878.3610.
| 510(k) Number | K243619 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 22, 2024 |
| Decision Date | October 30, 2025 |
| Days to Decision | 342 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | ESW — Prosthesis, Esophageal |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 878.3610 |