K251123
- 510(k) number
- K251123
- Device name
- Niti-S Biliary Stent; Niti-S Biliary Slim M Stent
- Applicant
- Taewoong Medical Co., Ltd. KR
- Product code
- FGE — Stents, Drains And Dilators For The Biliary Ducts
- Decision date
- 2025-12-29
- Date received
- 2025-04-11
- Decision
- Unknown
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K251123.pdf
Official FDA record: K251123
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.