510(k) K250217 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
AGNES Ultra
| Applicant | Agnes Medical Co., Ltd., Seongnam-Si, KR |
| Decision | Substantially Equivalent, Sep 3, 2025 |
| Received | Jan 24, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250217
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.