510(k) K252648 ยท PCU Pancreatic Stent, Covered, Metallic, Removable
Niti-S SPAXUS Stent
| Applicant | Taewoong Medical Co., Ltd., Gyeonggi-Do, KR |
| Decision | Substantially Equivalent, Mar 13, 2026 |
| Received | Aug 21, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K252648
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.