510(k) K250852 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Coolfase
| Applicant | Asterasys Co., Ltd., Seoul, KR |
| Decision | Substantially Equivalent, Oct 16, 2025 |
| Received | Mar 21, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250852
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.