510(k) K251327 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
XERF
| Applicant | Lutronic Corporation, Deogyang-Gu, KR |
| Decision | Substantially Equivalent, Aug 11, 2025 |
| Received | Apr 30, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K251327
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 14, 2025 | Lutronic Corporation XERF EFFECTOR 60. Electrosurgical unit. Open, Classified |
GEI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.