K250663
- 510(k) number
- K250663
- Device name
- Niti-S Duodenal Comfort Stent, Niti-S Colonic Comfort Stent
- Applicant
- Taewoong Medical Co., Ltd. KR
- Product code
- MUM — Stent, Metallic, Expandable, Duodenal
- Decision date
- 2025-03-31
- Date received
- 2025-03-05
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K250663.pdf
Official FDA record: K250663
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.