K240522
- 510(k) number
- K240522
- Device name
- Esophageal TTS Stent
- Applicant
- Taewoong Medical KR
- Product code
- ESW — Prosthesis, Esophageal
- Decision date
- 2024-03-22
- Date received
- 2024-02-23
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 1.1 MB · U.S. public domain
Also available from FDA: K240522.pdf
Official FDA record: K240522
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.