510(k) K233140 ยท NEY System, Ablation, Microwave And Accessories
Microwave Ablation Device (Exceed S10U); Sterile Microwave Ablation Probe (Exact)
| Applicant | Hygea Medical Technology Co., Ltd., Beijing, CN |
| Decision | Substantially Equivalent, Jan 31, 2024 |
| Received | Sep 27, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K233140
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.