K243619
- 510(k) number
- K243619
- Device name
- Niti-S Esophageal Stent; Esophageal TTS Stent
- Applicant
- Taewoong Medical Co., Ltd. KR
- Product code
- ESW — Prosthesis, Esophageal
- Decision date
- 2025-10-30
- Date received
- 2024-11-22
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K243619.pdf
Official FDA record: K243619
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.