510(k) K254290 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
ZenTite (Unicorn+); ZenTite (Unicorn+I); ZenTite (Unicorn+II); ZenTite (Unicorn+III)
| Applicant | Shenzhen Peninsula Medical Group, Shenzhen, CN |
| Decision | Substantially Equivalent, Jan 30, 2026 |
| Received | Dec 31, 2025 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K254290
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.