510(k) K253327 ยท ESW Prosthesis, Esophageal
HANAROSTENT Esophagus Upper (CCC)
| Applicant | M.I.Tech Co., Ltd., Pyeongtaek-Si, Gyeonggi-Do, KR |
| Decision | Substantially Equivalent, Oct 30, 2025 |
| Received | Sep 30, 2025 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K253327
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.