510(k) K251334 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
NEW DOUBLO 2.0
| Applicant | Hironic Co., Ltd., Yongin-Si, KR |
| Decision | Substantially Equivalent, Sep 29, 2025 |
| Received | Apr 30, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K251334
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.