K252648
- 510(k) number
- K252648
- Device name
- Niti-S SPAXUS Stent
- Applicant
- Taewoong Medical Co., Ltd. KR
- Product code
- PCU — Pancreatic Stent, Covered, Metallic, Removable
- Decision date
- 2026-03-13
- Date received
- 2025-08-21
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K252648.pdf
Official FDA record: K252648
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.