510(k) K260264 ยท ETA Replacement, Ossicular Prosthesis, Total
Medi Astro Total and Partial Ossicular Prostheses (Type TORP, Type PORP, and Type PISTON)
| Applicant | Shanghai Medi Astro Technology Co., Ltd., Shanghai, CN |
| Decision | Substantially Equivalent, Oct 14, 2026 |
| Received | Jan 28, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K260264
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.