510(k) K251813 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
CURIS II RF Generator (REF 360100-05)
| Applicant | Sutter Medizintechnik GmbH, Emmendingen, DE |
| Decision | Substantially Equivalent, Feb 11, 2026 |
| Received | Jun 13, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K251813
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.