K252648 is an FDA 510(k) clearance for the Niti-S SPAXUS Stent. This device is classified as a Pancreatic Stent, Covered, Metallic, Removable (Class II - Special Controls, product code PCU).
Submitted by Taewoong Medical Co., Ltd. (Gyeonggi-Do, KR). The FDA issued a Cleared decision on March 13, 2026, 204 days after receiving the submission on August 21, 2025.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5015. To Facilitate Transmural Endoscopic Drainage Of Pancreatic Pseudocysts.
| 510(k) Number | K252648 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 21, 2025 |
| Decision Date | March 13, 2026 |
| Days to Decision | 204 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | PCU — Pancreatic Stent, Covered, Metallic, Removable |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5015 |
| Definition | To Facilitate Transmural Endoscopic Drainage Of Pancreatic Pseudocysts |