510(k) K243042 ยท GEH Unit, Cryosurgical, Accessories
Co-Ablation System with Sterile Co-Ablation Probe
| Applicant | Hygea Medical Technology Co., Ltd., Beijing, CN |
| Decision | Substantially Equivalent, Jan 29, 2025 |
| Received | Sep 27, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243042
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.