K253327
- 510(k) number
- K253327
- Device name
- HANAROSTENT Esophagus Upper (CCC)
- Applicant
- M.I.Tech Co., Ltd. KR
- Product code
- ESW — Prosthesis, Esophageal
- Decision date
- 2025-10-30
- Date received
- 2025-09-30
- 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: K253327.pdf
Official FDA record: K253327
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.