510(k) K254185 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Potenza Prime
| Applicant | Jeisys Medical Incorporated, Seoul, KR |
| Decision | Substantially Equivalent, Sep 11, 2026 |
| Received | Dec 23, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K254185
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.