510(k) K233185 · GEI Electrosurgical, Cutting & Coagulation & Accessories
MODEL P8400 Controller for C2DXs Hemostatix Thermal Scalpel System
| Applicant | C2dx, Inc., Schoolcraft MI, US |
| Decision | Substantially Equivalent, Oct 24, 2023 |
| Received | Sep 28, 2023 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K233185
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.